A Predetermined Change Control Plan (PCCP) is a document, included in a marketing submission, that describes planned modifications to an AI/ML-enabled device, the methods used to develop, validate, and implement those modifications, and the impact on the device. A PCCP has three parts: a description of modifications, a modification protocol (data management, retraining, performance evaluation and update procedures) and an impact assessment. Once authorized, changes made in line with the plan do not need a new submission. FDA finalized its guidance on PCCPs for AI-enabled device software functions in December 2024, and section 515C of the FD&C Act, added in 2022, gives FDA the authority to approve them for all devices.

Why it matters

PCCPs let manufacturers update AI/ML models within an authorized envelope without a new submission, while preserving safety and effectiveness controls.

Common pitfalls

•Misunderstanding that a PCCP grants blanket approval for any change; only modifications explicitly covered and detailed in the authorized plan are permitted without new submission.
•Failing to adequately specify validation methods or performance evaluation procedures in the PCCP, leading to potential FDA rejection or challenges during post-market implementation.
•Assuming PCCPs eliminate all regulatory oversight for AI/ML updates; significant deviations or changes outside the scope of the authorized plan still require new regulatory review.
•Underestimating the level of detail required in the PCCP, particularly regarding data management and retraining protocols, which are crucial for successful implementation.

Sources

FDA PCCP Guidance · FDA
FDA - AI/ML-Enabled Medical Devices · FDA
IMDRF - Software as a Medical Device · IMDRF

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