InstrumentGuidance
FDA guidance: Predetermined Change Control Plans for AI enabled devices
Is this legally binding?
Guidance. Voluntary guidance. Best practice, not obligation, until a contract or a regulator cites it.
The mechanism that lets a learning medical device keep learning without a new clearance each time. FDA guidance is expressly non binding, but a submission that ignores it is a submission that will not clear.
Instrument record
- Short name
- FDA PCCP guidance
- Date
- 2024-12-04
- Version
- Not versioned
- Cluster
- core
What this connects to
2 relations. Official relations are the ones the source documents state; anything marked GAGE analysis is our reading, not an agency's.
Verified against the official source on 2026-08-18. GAGE is not affiliated with or endorsed by any agency named here, and nothing on this page is legal advice. How this is built and checked.