Predetermined Change Control Plan
Also called: PCCP
An FDA mechanism letting a manufacturer specify in advance how a model may be updated after authorization without requiring a new submission each time.
Traditional device regulation assumes a fixed product. Machine learning models improve with more data, and requiring a new submission for every update would freeze them at their authorized state. A PCCP lets a manufacturer pre-specify the modifications it intends to make, the methods used, and the acceptance criteria.
Where This Gets Misread
A PCCP means the device in your department may not be the device that was validated, within pre-agreed bounds. That is deliberate and reasonable, and it also means "FDA cleared" describes a version and a change envelope rather than a fixed artifact. Knowing which version you are running becomes a real question.