Tracker → US
FDA CDRH AI/ML
FDA guidance on AI-enabled device software functions
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
- monthly
- Crawlable
- unknown
- Text licence
- freely reproducible
- Primary source
- Primary source (fda.gov)
Current status
Status not yet verified against the primary source. Recorded as unknown rather
than estimated.
Scope
FDA guidance addressing artificial-intelligence-enabled device software functions and predetermined change control plans.
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