Predetermined Change Control Plan (PCCP)
A pre-specified, pre-authorized description of the kinds of updates an AI-enabled system is allowed to make after deployment, used in United States medical-device regulation to govern models that continue learning after release. The concept generalizes beyond medical devices: any vendor update, authorized in advance or not, should reopen an evaluation report's evidence and review trigger rather than being treated as routine maintenance.
Defined in 2 GAGE programs, which carry 2 distinct definitions of it. The wording above is taught in AI Governance: Applied Mastery.
How each discipline defines it
The same term does different work depending on who is using it. These are the definitions as each program teaches them, unedited.
A pre-specified, pre-authorized description of the kinds of updates an AI-enabled system is allowed to make after deployment, used in United States medical-device regulation to govern models that continue learning after release. The concept generalizes beyond medical devices: any vendor update, authorized in advance or not, should reopen an evaluation report's evidence and review trigger rather than being treated as routine maintenance.
The FDA's formal term for a pre-specified description of anticipated future AI/ML model modifications submitted as part of a US device clearance; NMPA's 2025 to 2026 change-control instruments move toward a functionally similar mechanism without using identical terminology or an identical formal submission structure, a distinction this topic treats carefully rather than claiming cross-jurisdictional equivalence.
Where it is taught
The exact lessons this term appears in. The first 7 topics of every program are free with a free account.
- The evaluation report: evidence that your trust levels are earned, not hoped · Evaluation and Trust, AI Governance: Applied Mastery
Terms it appears with
Not an alphabetical neighbourhood: these are the terms taught in the same lessons, ranked by how often they appear together.