GxPlex

FDA PCCP

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

final

Last verified: Last observed: no observation recorded Tier: 1 · Sector: medical device
Authority
US Food and Drug Administration
Jurisdiction
US
Status
final
Effective date
—
Last changed
—
Last verified
:
Watch cadence
monthly
Crawlable
unknown
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov
Topics
artificial intelligence · change control · software

Current status#

Recorded as final against the primary source on 2026-07-28. See the evidence record for the text that supported it.

Scope#

FDA guidance on predetermined change control plans for artificial-intelligence-enabled device software functions.

Key dates#

No dates have been verified against the primary source for this entry.

Sources#

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions [instrument record]. Observed 27 July 2026. https://gxplex.com/instrument/fda-pccp Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence

BibTeX

@misc{gxplexinstrumentfdapccp,
  author       = {{GxPlex}},
  title        = {{Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions}},
  year         = {2026},
  note         = {instrument record, observed 27 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-pccp}},
  urldate      = {2026-07-28},
  url          = {https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence}
}

APA

GxPlex. (2026). Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions [instrument record]. Retrieved 27 July 2026, from https://gxplex.com/instrument/fda-pccp

Observation history

No observations recorded yet.

Change history

Sources

Last updated: