PCCP
Predetermined Change Control Plan
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A Predetermined Change Control Plan is a document, authorized as part of a device marketing submission, that specifies planned future modifications to a device (notably AI/ML-enabled software) and the methods that will be used to develop, validate, and implement those changes. Once authorized, changes made within the plan can be implemented without a new premarket submission each time.
The PCCP is FDA’s answer to the "locked vs adaptive" problem for AI/ML software, where periodic retraining or updates would otherwise trigger repeated submissions. It typically contains a description of the anticipated modifications, a modification protocol (how each change is developed, verified, validated, and monitored), and an impact assessment.
The FD&C Act was amended (section 515C) to establish the PCCP mechanism, and FDA has issued guidance on how to structure one — allowing pre-authorized, bounded evolution of a device while keeping the changes within a validated, transparent envelope.
- —Pre-authorizes bounded future device changes in the submission.
- —Central to AI/ML "adaptive" software regulation.
- —Contains anticipated changes, a modification protocol, and impact assessment.
- —Statutory basis in FD&C Act §515C.
FDA guidance on Predetermined Change Control Plans for AI-enabled device software functions (2024); FD&C Act §515C (added by FDORA, 2022).
Frequently asked questions
What does PCCP stand for?
PCCP stands for Predetermined Change Control Plan.
What is PCCP?
A Predetermined Change Control Plan is a document, authorized as part of a device marketing submission, that specifies planned future modifications to a device (notably AI/ML-enabled software) and the methods that will be used to develop, validate, and implement those changes. Once authorized, changes made within the plan can be implemented without a new premarket submission each time.
Which regulations cover PCCP?
FDA guidance on Predetermined Change Control Plans for AI-enabled device software functions (2024); FD&C Act §515C (added by FDORA, 2022).