United States (federal) · guidance
FDA PCCP: what it requires, and the records to keep
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.
01 / What it requires
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 / AI work
Where it touches AI work
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.
03 / Dates
The dates that matter
FDORA adds FD&C Act section 515C authorizing PCCPs
Draft guidance issued (machine-learning device software functions)
FDA, Health Canada and MHRA publish PCCP guiding principles
Final guidance issued, scope widened to AI-enabled device software functions
FDA guidance page shows an August 2025 version of the final guidance
04 / Enforcement
Who enforces it
FDA. A device changed outside an authorized PCCP without a required submission may be adulterated or misbranded under the FD&C Act, exposing the firm to warning letters, recalls, seizure, injunction and civil money penalties.
05 / Records
Records an organisation keeps
What an auditor or an inquiry usually asks to see. Your obligations depend on your role and your facts.
- 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.
QUESTIONS
The questions that come next
What goes in an FDA Predetermined Change Control Plan (PCCP)?+
A PCCP has three parts: a Description of Modifications listing the specific planned changes to the AI-enabled device software; a Modification Protocol explaining how each change will be developed, validated and implemented, with acceptance criteria; and an Impact Assessment of the benefits and risks of the changes. Once FDA authorizes the plan in a 510(k), De Novo or PMA, changes made according to it need no new marketing submission. Changes outside the plan or the device's intended use still do. FDA finalized the guidance in December 2024, and its page now shows an August 2025 version. Read the full answer
Can I update my AI model after 510(k) clearance without a new submission?+
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. Read the full answer
How do I prove my AI model hasn't drifted since validation?+
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. Read the full answer
SOURCES
Go back to the source
U.S. Food and Drug Administration
Congressional Research Service (via EveryCRSReport)
CHANGE LOG
What changed, and when
Rebuilt from primary sources; facts checked on this date.
Related: FDA PCCP for medicine AI workflows · NIST AI RMF · OMB M-25-21/22 · DoW RAI S&IP · EO 14179 · FIPS 140-3 · SHA-256 / FIPS 180-4