What is a PCCP?

In short: A Predetermined Change Control Plan is FDA's mechanism for updating AI-enabled devices without a new submission: you pre-specify anticipated model changes, the protocol for making them, and the impact assessment, and FDA authorizes the plan with your original clearance. Only changes within the plan's bounds are covered.

The problem PCCPs solve

Without a PCCP, any modification to your model's function that could affect safety or effectiveness generally requires a new FDA submission — a real friction point for AI/ML products that are meant to keep learning and improving after launch, not stay frozen at their cleared state. A PCCP lets you define, up front, the specific kinds of updates you anticipate making, submit that plan alongside your original 510(k) or De Novo submission, and have FDA authorize the plan itself as part of your clearance — so that future updates falling within its bounds don't require a fresh submission each time.

The three components

A PCCP has three parts: the Description of Modifications, specifying exactly what kinds of changes are anticipated (a retraining cadence, an expanded population, a new data source); the Modification Protocol, describing the methods used to develop, validate, and implement each anticipated change; and the Impact Assessment, analyzing the benefits and risks of the anticipated modifications and how they'll be communicated to users. All three need to be specific enough for FDA to meaningfully evaluate — a vague PCCP promising "ongoing improvement" without defined bounds won't be accepted.

Where this stands, and its limit

Final guidance specifically for AI/ML-enabled device software functions was issued in December 2024, and the mechanism is on solid regulatory footing for that use case; general (non-AI) device PCCP guidance remains in draft form. The limit worth remembering: a PCCP only covers changes that fall within its pre-specified bounds. An update outside that scope — a genuinely new intended use, a materially different population — still requires a new submission. Write the PCCP alongside your original submission, not after, since retrofitting one later doesn't help changes you've already made.

Where next: FDA PCCP: Updating AI Models After Clearance · What software documentation does FDA expect?

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