FDA Predetermined Change Control Plans for AI Devices
How a cleared AI device may be updated without a new submission.
- Cost
- Free
- Hardware
- Runs on any laptop
- Scanner
- Not required
- Your data
- Stays on your machine
- Licence
- unknown
- Maturity
- production
- From
- US FDA
What it is
FDA guidance on describing, in advance, the modifications an AI-enabled device may undergo after clearance and how they will be validated — the mechanism that makes a continuously-learning device regulable at all.
Licence notes
Published document; check the publisher's terms for reuse.
Related
Catalogued 2026-08-02, last checked 2026-08-02. View the source record · Report an error