FDA draft guidance: AI enabled device software functions
Is this legally binding?
Consultation. Proposed, not final. Read it, plan for it, and do not treat it as settled.
Proposed and not final. Nothing here can be enforced against you yet.
Announced 7 January 2025 and still in draft as of this dataset's verification date. It is the closest thing US federal policy has to an AI transparency labelling requirement, and it applies to medical devices only.
Instrument record
- Short name
- FDA lifecycle draft
- Date
- 2025-01-07
- 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.
Learn this properly
This page tells you what FDA draft guidance: AI enabled device software functions is and whether it binds you. The AI Governance program teaches the whole discipline, with dedicated coverage of the Singapore governance stack and the MAS regime, and every topic is passed by explaining it back in your own words, graded against the source.
See the AI Governance programVerified 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.
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