Question · FDA PCCP
How do I prove my AI model hasn't drifted since validation?
FDA's final guidance explains what to put in a predetermined change control plan so that pre-specified changes to an AI-enabled device, such as retraining, can be made after authorization without a new marketing submission for each change.
01 / The answer
The short answer
You show it by re-running the same fixed, documented evaluation and comparing each result with the validation baseline. Keep the original test data, metrics and acceptance criteria; evaluate new real-world or held-out data at set intervals; and log each run with the model version, date, data used and results, including results for patient subgroups. If the device has an authorized PCCP, its Modification Protocol defines the metrics and thresholds that apply. Whether a measured change is acceptable remains a clinical and regulatory judgment for the manufacturer.
02 / The rule
What FDA PCCP requires
FDA's final guidance explains what to put in a predetermined change control plan so that pre-specified changes to an AI-enabled device, such as retraining, can be made after authorization without a new marketing submission for each change. It is the main route for updating a cleared or approved AI model while staying within the law.
- 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.
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 · What goes in an FDA Predetermined Change Control Plan (PCCP)? · Can I update my AI model after 510(k) clearance without a new submission?