Question · FDA PCCP
Can I update my AI model after 510(k) clearance without a new submission?
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
Yes, if the change is covered by a predetermined change control plan that FDA authorized for the device. FDA regulations exempt changes consistent with a PCCP authorized under section 515C of the FD&C Act, which the Food and Drug Omnibus Reform Act of 2022 added, from the new-510(k) requirement (21 CFR 807.81(b)(1)(ii)). Without a PCCP, or for changes outside it, the normal rule applies: a new 510(k) is needed for a change that could significantly affect safety or effectiveness, or a major change in intended use (21 CFR 807.81(a)(3)). Deciding which changes qualify is the manufacturer's regulatory call, subject to FDA.
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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