Tracker → US
FDA AI guidance
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
not yet verified
Not yet verified. The status of this instrument has not been
confirmed against its primary source. It is recorded as unknown rather than
estimated. Consult the
primary source directly.
- Authority
- US Food and Drug Administration
- Jurisdiction
- US
- Status
- not yet verified
- Effective date
- —
- Last changed
- —
- Last verified
- : not yet verified
- Watch cadence
- weekly
- Crawlable
- yes · renders server-side · returns non-200 to an AI-agent user-agent
- Text licence
- freely reproducible
- Primary source
- Primary source (fda.gov)
- Topics
- artificial intelligence · credibility assessment
Current status
Status not yet verified against the primary source. Recorded as unknown rather than estimated.
Scope
FDA draft guidance describing a risk-based credibility assessment framework for AI models used to support regulatory decision-making.
Key dates
No dates have been verified against the primary source for this entry.
Sources
NEEDS VERIFICATION. The regulatory status of this instrument has not yet been
confirmed against its primary source. It is recorded as unknown rather than
estimated. See /methodology for what verification means here.
Observation history
No observations recorded yet.
Sources