GxPlex

Observation series — Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions

← FDA PCCP

194 observation(s) recorded. 194 carry an address; none is without one. 193 retained normalised text and hold a digest. 1 hold none: 1 where no response arrived; and none was hashed.

Each observation is addressed by this row’s identifier, the date it was observed, and its sequence within that date — the same key /api/v1/series.jsonl publishes as `sequence`, counted in the order the store recorded them.

This digest is a leaf of the integrity root, and the command that recomputes it is published at /verify/.

Every addressed record below carries its own citation, naming the day, the URL that answered, the response as recorded, and the digest where one exists. Where none exists the citation says so and asserts no digest.

The GXP-OBS statements on the field a column renders: Normalised textcontent_length · The document observation · GXP-OBS version 1What it records Characters of normalised content.What it does not claim It measures the normalisation, not the document, and it is not a measure of how much a document says.Absent or null means Written as 0 wherever no digest was taken. A 0 here is the absence of a measurement and never a measured empty document.In the glossary · GXP-OBS
Address Date Outcome Method Normalised text SHA-256 of normalised text
2026-07-28·1
Cite this observation 
GxPlex observation record fda-pccp 2026-07-28·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-28 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,195 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-28-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-28·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,195 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-28·2
Cite this observation 
GxPlex observation record fda-pccp 2026-07-28·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-28 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,195 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-28-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-28·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,195 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-28·3
Cite this observation 
GxPlex observation record fda-pccp 2026-07-28·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-28 (record 3 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,195 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-28-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-28·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,195 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-28·4
Cite this observation 
GxPlex observation record fda-pccp 2026-07-28·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-28 (record 4 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,195 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-28-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-28·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,195 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·1
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·2
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·3
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 3 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·4
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 4 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·5
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 5 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·6
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 6 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·7
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·7
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 7 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-7
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·7; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·8
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·8
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 8 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-8
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·8; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·9
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·9
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 9 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-9
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·9; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·10
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·10
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 10 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-10
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·10; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·11
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·11
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 11 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29 — the day this
             observation was recorded, UTC.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-11
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·11; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·12
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·12
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 12 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-12
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·12; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·13
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·13
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 13 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-13
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·13; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-29·14
Cite this observation 
GxPlex observation record fda-pccp 2026-07-29·14
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-29 (record 14 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-29-14
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-29·14; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·1
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·2
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·3
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 3 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·4
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 4 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·5
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 5 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·6
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 6 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·7
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·7
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 7 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-7
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·7; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·8
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·8
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 8 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-8
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·8; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·9
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·9
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 9 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-9
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·9; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·10
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·10
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 10 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-10
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·10; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·11
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·11
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 11 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-11
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·11; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·12
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·12
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 12 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-12
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·12; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·13
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·13
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 13 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-13
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·13; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·14
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·14
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 14 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-14
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·14; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·15
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·15
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 15 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-15
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·15; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·16
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·16
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 16 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,203 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-16
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·16; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,203 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·17
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·17
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 17 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-17
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·17; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-30·18
Cite this observation 
GxPlex observation record fda-pccp 2026-07-30·18
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-30 (record 18 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-30-18
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-30·18; the bundle states
             what its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·1
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·2
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·3
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 3 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·4
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 4 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·5
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 5 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·6
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 6 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-07-31·7
Cite this observation 
GxPlex observation record fda-pccp 2026-07-31·7
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-07-31 (record 7 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-07-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-07-31-7
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-07-31·7; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-01·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-01·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-01 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,198 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-01 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-01-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-01·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,198 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-01·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-01·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-01 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,198 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-01 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-01-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-01·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,198 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-01·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-01·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-01 (record 3 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-01-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-01·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-02·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-02·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-02 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-02-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-02·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-02·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-02·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-02 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-02-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-02·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-02·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-02·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-02 (record 3 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-02-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-02·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-03·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-03·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-03 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-03 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-03-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-03·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-03·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-03·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-03 (record 2 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-03 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-03-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-03·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-03·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-03·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-03 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-03 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-03-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-03·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-04·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-04·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-04 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,192 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-04 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-04-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-04·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,192 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-04·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-04·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-04 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,192 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-04 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-04-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-04·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,192 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-05·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-05·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-05 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-05-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-05·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-05·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-05·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-05 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-05-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-05·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-05·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-05·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-05 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-05-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-05·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-06·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-06·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-06 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-06 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-06-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-06·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-06·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-06·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-06 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-06 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-06-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-06·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-07·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-07·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-07 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,196 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-07 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-07-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-07·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,196 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-08·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-08·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-08 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,226 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-08 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-08-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-08·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,226 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-08·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-08·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-08 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,299 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-08 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-08-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-08·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,299 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-08·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-08·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-08 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,299 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-08 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-08-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-08·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,299 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-08·4
Cite this observation 
GxPlex observation record fda-pccp 2026-08-08·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-08 (record 4 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,299 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-08 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-08-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-08·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,299 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,299 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,299 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,299 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,299 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,299 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,299 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·4
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 4 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·5
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 5 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·6
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 6 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·7
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·7
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 7 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-7
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·7; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-09·8
Cite this observation 
GxPlex observation record fda-pccp 2026-08-09·8
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-09 (record 8 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-09-8
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-09·8; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-10·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-10·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-10 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-10-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-10·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-10·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-10·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-10 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-10-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-10·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-10·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-10·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-10 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-10-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-10·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-10·4
Cite this observation 
GxPlex observation record fda-pccp 2026-08-10·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-10 (record 4 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-10-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-10·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-10·5
Cite this observation 
GxPlex observation record fda-pccp 2026-08-10·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-10 (record 5 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,188 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-10-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-10·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,188 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-10·6
Cite this observation 
GxPlex observation record fda-pccp 2026-08-10·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-10 (record 6 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,200 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-11 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-10-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-10·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,200 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-11·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-11·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-11 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,200 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-11 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-11-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-11·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,200 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-11·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-11·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-11 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-11-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-11·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-11·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-11·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-11 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-11-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-11·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·4
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 4 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·5
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 5 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·6
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 6 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·7
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·7
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 7 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-7
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·7; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·8
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·8
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 8 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-8
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·8; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-12·9
Cite this observation 
GxPlex observation record fda-pccp 2026-08-12·9
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-12 (record 9 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-12-9
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-12·9; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-13·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-13·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-13 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,194 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-13 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-13-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-13·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,194 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-14·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-14·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-14 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,187 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-14 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-14-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-14·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,187 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-15·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-15·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-15 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,196 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-15 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-15-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-15·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,196 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-15·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-15·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-15 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,196 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-15 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-15-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-15·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,196 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-15·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-15·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-15 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,196 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-15 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-15-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-15·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,196 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-16·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-16·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-16 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-16 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-16-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-16·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-16·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-16·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-16 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-16 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-16-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-16·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-16·3
Cite this observation 
GxPlex observation record fda-pccp 2026-08-16·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-16 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-16 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-16-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-16·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-16·4
Cite this observation 
GxPlex observation record fda-pccp 2026-08-16·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-16 (record 4 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-16 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-16-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-16·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-17·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-17·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-17 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,193 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-17 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-17-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-17·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,193 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-18·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-18·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-18 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-18 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-18-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-18·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-19·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-19·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-19 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,199 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-19 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-19-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-19·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,199 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-20·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-20·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-20 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,194 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-20 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-20-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-20·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,194 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-21·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-21·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-21 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,196 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-21 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-21-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-21·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,196 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-22·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-22·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-22 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,185 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-22 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-22-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-22·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,185 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-22·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-22·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-22 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,185 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-22 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-22-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-22·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,185 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-23·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-23·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-23 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,195 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-23 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-23-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-23·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,195 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-24·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-24·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-24 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,190 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-24 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-24-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-24·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,190 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-25·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-25·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-25 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-25 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-25-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-25·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-25·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-25·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-25 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,191 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-25 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-25-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-25·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,191 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-26·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-26·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-26 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,182 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-26 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-26-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-26·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,182 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-26·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-26·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-26 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,182 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-26 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-26-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-26·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,182 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-27·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-27·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-27 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,194 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-27 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-27-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-27·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,194 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-28·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-28·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-28 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,194 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-28 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-28-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-28·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,194 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-29·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-29·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-29 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-29 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-29-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-29·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-29·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-29·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-29 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-29 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-29-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-29·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-30·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-30·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-30 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,184 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-30-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-30·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,184 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-30·2
Cite this observation 
GxPlex observation record fda-pccp 2026-08-30·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-30 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,184 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-30-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-30·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,184 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-08-31·1
Cite this observation 
GxPlex observation record fda-pccp 2026-08-31·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-08-31 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,199 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-08-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-08-31-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-08-31·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,199 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-01·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-01·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-01 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,183 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-01 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-01-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-01·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,183 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-02·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-02·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-02 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 37,189 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-02-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-02·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 37,189 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-02·2
Cite this observation 
GxPlex observation record fda-pccp 2026-09-02·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-02 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,728 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-02-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-02·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,728 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-03·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-03·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-03 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,718 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-03 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-03-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-03·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,718 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-04·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-04·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-04 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,688 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-04 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-04-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-04·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,688 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-04·2
Cite this observation 
GxPlex observation record fda-pccp 2026-09-04·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-04 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,688 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-04 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-04-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-04·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,688 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·2
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·3
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·3
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 3 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-3
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·3; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·4
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·4
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 4 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-4
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·4; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·5
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·5
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 5 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-5
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·5; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·6
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·6
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 6 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-6
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·6; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·7
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·7
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 7 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-7
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·7; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·8
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·8
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 8 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-8
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·8; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-05·9
Cite this observation 
GxPlex observation record fda-pccp 2026-09-05·9
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-05 (record 9 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,679 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-05-9
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-05·9; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,679 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-06·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-06·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-06 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,684 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-06 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-06-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-06·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,684 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-07·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-07·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-07 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,675 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-07 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-07-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-07·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,675 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-08·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-08·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-08 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,728 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-08 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-08-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-08·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,728 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-09·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-09·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-09 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,678 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-09-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-09·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,678 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-10·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-10·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-10 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,685 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-10-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-10·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,685 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-11·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-11·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-11 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,678 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-11 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-11-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-11·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,678 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-12·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-12·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-12 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,680 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-12-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-12·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,680 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-13·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-13·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-13 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,682 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-13 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-13-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-13·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,682 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-14·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-14·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-14 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,681 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-14 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-14-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-14·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,681 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-15·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-15·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-15 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,718 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-15 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-15-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-15·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,718 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-16·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-16·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-16 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,685 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-16 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-16-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-16·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,685 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-17·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-17·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-17 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,834 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-17 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-17-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-17·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,834 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-18·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-18·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-18 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,841 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-18 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-18-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-18·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,841 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-19·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-19·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-19 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-19 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-19-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-19·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-20·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-20·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-20 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,846 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-20 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-20-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-20·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,846 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-21·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-21·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-21 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,833 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-21 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-21-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-21·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,833 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-22·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-22·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-22 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,841 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-22 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-22-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-22·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,841 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-23·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-23·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-23 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,842 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-23 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-23-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-23·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,842 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-24·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-24·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-24 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,838 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-24 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-24-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-24·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,838 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-25·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-25·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-25 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-25 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-25-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-25·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-26·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-26·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-26 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,842 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-26 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-26-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-26·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,842 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-27·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-27·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-27 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,834 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-27 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-27-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-27·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,834 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-28·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-28·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-28 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,843 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-28 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-28-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-28·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,843 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-29·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-29·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-29 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,838 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-29 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-29-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-29·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,838 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-09-30·1
Cite this observation 
GxPlex observation record fda-pccp 2026-09-30·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-09-30 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,844 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-09-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-09-30-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-09-30·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,844 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-01·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-01·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-01 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,836 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-01 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-01-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-01·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,836 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-01·2
Cite this observation 
GxPlex observation record fda-pccp 2026-10-01·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-01 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,836 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-01 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-01-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-01·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,836 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-02·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-02·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-02 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,841 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-02-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-02·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,841 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-03·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-03·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-03 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,887 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-03 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-03-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-03·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,887 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-04·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-04·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-04 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,835 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-04 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-04-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-04·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,835 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-05·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-05·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-05 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,835 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-05 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-05-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-05·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,835 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-06·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-06·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-06 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,846 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-06 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-06-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-06·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,846 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-07·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-07·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-07 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-07 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-07-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-07·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-08·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-08·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-08 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,840 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-08 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-08-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-08·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,840 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-09·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-09·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-09 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,838 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-09 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-09-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-09·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,838 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-10·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-10·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-10 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,847 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-10 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-10-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-10·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,847 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-11·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-11·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-11 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-11 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-11-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-11·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-11·2
Cite this observation 
GxPlex observation record fda-pccp 2026-10-11·2
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-11 (record 2 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-11 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-11-2
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-11·2; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-12·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-12·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-12 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,843 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-12 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-12-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-12·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,843 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-13·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-13·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-13 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,838 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-13 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-13-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-13·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,838 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-14·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-14·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-14 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,842 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-14 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-14-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-14·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,842 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-15·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-15·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-15 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,838 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-15 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-15-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-15·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,838 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-16·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-16·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-16 (record 1 of that day)
Requested:   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (no answering URL was recorded for this observation)
Response:    NO RESPONSE ARRIVED, fetched blocked, URLError
             The collector records a status of 0 and 0 bytes when no response
             arrived; neither is a measurement, and neither is published as
             one.
Digest:      NONE RECORDED. No response arrived, and no normalised text was
             retained for this observation, so nothing was hashed. This
             citation asserts no digest.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-16 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-16-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-16·1; the bundle states what
             its proofs cover and its signature state)
 no response arrived · URLError blocked — no response arrived on this occasion, so nothing was hashed
2026-10-17·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-17·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-17 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,836 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-17 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-17-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-17·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,836 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-18·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-18·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-18 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,845 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-18 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-18-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-18·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,845 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-19·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-19·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-19 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-19 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-19-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-19·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-20·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-20·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-20 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,847 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-20 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-20-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-20·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,847 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-21·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-21·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-21 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,830 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-21 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-21-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-21·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,830 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-22·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-22·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-22 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,843 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-22 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-22-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-22·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,843 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-23·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-23·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-23 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,836 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-23 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-23-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-23·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,836 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-24·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-24·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-24 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,844 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-24 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-24-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-24·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,844 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-25·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-25·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-25 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,831 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-25 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-25-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-25·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,831 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-26·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-26·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-26 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,892 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-26 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-26-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-26·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,892 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-27·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-27·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-27 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,879 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-27 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-27-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-27·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,879 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-28·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-28·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-28 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,842 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-28 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-28-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-28·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,842 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-29·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-29·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-29 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,837 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-29 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-29-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-29·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,837 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-30·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-30·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-30 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,839 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-30 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-30-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-30·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,839 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-10-31·1
Cite this observation 
GxPlex observation record fda-pccp 2026-10-31·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-10-31 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,830 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-10-31 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-10-31-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-10-31·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,830 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-11-01·1
Cite this observation 
GxPlex observation record fda-pccp 2026-11-01·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-11-01 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,838 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-11-01 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-11-01-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-11-01·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,838 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
2026-11-02·1
Cite this observation 
GxPlex observation record fda-pccp 2026-11-02·1
Document:    Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Observed:    2026-11-02 (record 1 of that day)
Answered at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Response:    HTTP 200, fetched direct, 36,828 bytes returned
Digest:      SHA-256 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0
             2,410 characters of normalised text.
             The digest is of the NORMALISED text, not of the bytes served:
             tags, scripts, navigation and volatile strings are removed before
             hashing, so hashing the source as served will not reproduce it.
             Normalisation is described at https://gxplex.com/how/; the command
             that recomputes a digest is published at
             https://gxplex.com/verify/.
Capture:     https://web.archive.org/web/20260729221357/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
             (Internet Archive, submitted 2026-07-29, before this observation
             was recorded on 2026-11-02 UTC. NOT a capture of this
             observation.)
Permalink:   https://gxplex.com/observations/fda-pccp#obs-2026-11-02-1
Full record: https://gxplex.com/api/v1/series.jsonl
Bundle:      https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
             (this observation under key 2026-11-02·1; the bundle states what
             its proofs cover and its signature state)
 HTTP 200 · 36,828 bytes returned direct 2,410 chars 4c3dca909c349ed76c1c1fe7ad8c31b368bb8829fa3175fe05f3cc93a68d20c0

Every record above is published untruncated at /api/v1/series.jsonl, which carries the same sequence these addresses are built from.