Glossary · USA: FDA device and drug rules
Predetermined change control plan (PCCP)
Also known as: PCCP, Predetermined change control plan for AI-enabled device software functions
A predetermined change control plan (PCCP) is a plan, authorized by the US FDA as part of a device's marketing submission under section 515C of the FD&C Act, that describes specific planned modifications to the device and how they will be developed, validated and implemented. Modifications made in line with the authorized PCCP don't need a new marketing submission.
- USA
- AI
In one sentence
A PCCP lets FDA authorize planned device changes in advance, such as AI model updates, so they don't each need a new 510(k), De Novo or PMA.
Example
A maker of an AI-based radiology triage tool includes a PCCP in its 510(k), covering retraining on new data from additional scanner models under a fixed protocol and performance thresholds; later retrained versions ship without a new 510(k).
How it applies
- Legal basis: Section 515C of the FD&C Act, added by the Food and Drug Omnibus Reform Act of 2022 (FDORA), allows PCCPs for devices cleared under 510(k), granted De Novo or approved through PMA.
- Three components: A description of the planned modifications; a modification protocol describing the methods for developing, validating and implementing them; and an impact assessment of the benefits and risks.
- AI guidance: FDA's final guidance of December 2024 sets out recommendations for PCCPs for AI-enabled device software functions, such as retraining or performance improvements within the defined scope.
- Limits: Changes outside the authorized plan, or that change the intended use beyond it, still need a new submission. A PCCP does not authorize continuously learning changes that are not specified and validated in advance.
- Technical documentation: Keep the authorized PCCP under change control and record for each release which planned modification it implements, the validation results against the protocol and the updated labeling.
PCCP vs. the EU approach
EU law has no general equivalent authorized with the device. Under the MDR and IVDR, significant changes are assessed by the notified body; under the AI Act, a substantial modification of a high-risk AI system triggers a new conformity assessment, while changes predetermined by the provider at the initial assessment and documented in the technical documentation are not substantial modifications. Check the current MDCG guidance on how this works for AI-enabled medical devices; see AI in medical devices.