GxPlex

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

← FDA PCCP

147 observation(s) recorded. 147 carry an address; none is without one. 147 retained normalised text and hold a digest.

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.

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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 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/methodology; 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
 HTTP 200 · 36,841 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.