Medicine · FDA PCCP
FDA PCCP for clinical AI workflows
FDA PCCP in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.
01 / The rule
What FDA PCCP requires
Manufacturers of medical devices with AI-enabled device software functions seeking 510(k) clearance, De Novo classification or PMA approval, including device-led combination products.
- 01Describe each planned modification specifically enough for FDA to assess it (Description of Modifications).
- 02Specify how each modification will be developed, validated and implemented, with acceptance criteria (Modification Protocol).
- 03Assess the benefits and risks of the planned modifications, individually and together (Impact Assessment).
- 04Keep every modification within the device's authorized intended use.
- 05Implement changes only as the authorized PCCP describes; changes outside it need a new submission.
- 06Update labeling and keep version control and quality system records for each implemented change.
02 / In this sector
In a clinical AI workflow
The guidance is written for AI-enabled device software functions, the final version having broadened the draft's machine-learning-only scope. It is how a manufacturer gets authorization in advance for model retraining or performance updates.
Clinical committees and health system AI governance.
HHS §1557 · HIPAA · FDA PCCP.
03 / Records
Records to keep
- 01Authorized PCCP from the 510(k), De Novo or PMA file
- 02Verification and validation results for each implemented modification
- 03Version history linking each released model to the PCCP
- 04Updated labeling describing the modification and its performance
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
SOURCES
Go back to the source
U.S. Food and Drug Administration
Congressional Research Service (via EveryCRSReport)
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Related: FDA PCCP: the full guide · FDA PCCP for defense · FDA PCCP for law · FDA PCCP for education