PCCP for AI medical devices: planning model updates with the FDA
Teams that build AI-enabled device software often want to retrain or improve a model after launch. This page explains how the FDA's Predetermined Change Control Plan (PCCP) guidance lets them plan those changes up front.
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What a PCCP allows
Section 515C of the Federal Food, Drug, and Cosmetic Act provides that a new 510(k) or a PMA supplement is not required for a change that is consistent with a PCCP cleared or approved by FDA. The guidance covers modifications that would otherwise require a new marketing submission.
A device with a PCCP can be authorized through the PMA, 510(k) or De Novo pathway. The plan should be discussed in the marketing submission alongside the device description, labeling and the safety and effectiveness or substantial equivalence assessment.
The building blocks of the plan
The final PCCP guidance is organized around a Description of Modifications, a Modification Protocol and an Impact Assessment, with traceability between the planned changes and the protocol.
The Modification Protocol describes data management practices, re-training practices, performance evaluation and update procedures.
Frequently asked questions
Does a PCCP cover minor changes that never needed a submission?
No. The guidance states that a PCCP is meant for modifications that generally would otherwise require a new marketing submission, and it does not address plans for changes that would not require one.
Can FDA require labeling for the planned changes?
Yes. Section 515C allows FDA to require that a PCCP include labeling for safe and effective use of the device as it changes under the plan.
Is the separate AI lifecycle guidance final?
No. The lifecycle guidance for AI-enabled device software functions is a draft, while the PCCP marketing submission guidance is final.
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