Short answer (updated Oct 17, 2026): FDA has no guidance specific to generative-AI medical devices yet. Its Digital Health Center of Excellence published a discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices, and is taking feedback under docket FDA-2026-N-7874 until October 19, 2026.
Key facts
| Document | Discussion paper and request for feedback (FDA says it is not draft or final guidance) |
|---|---|
| Issued by | Digital Health Center of Excellence, CDRH |
| FDA page current as of | Aug 18, 2026 |
| Docket | FDA-2026-N-7874 (Regulations.gov) |
| Feedback due | Oct 19, 2026 |
| Topics | Risk assessment, premarket evaluation, postmarket monitoring, and other topics such as foundation models |
What's next
CDRH's FY2027 guidance agenda, announced Oct 1, 2026, lists a draft guidance on generative AI-enabled conversational devices for mental health disorders as an A-list priority, and places risk assessments for generative AI-enabled devices in its lower-priority third tier. Comments on the agenda are due Nov 30, 2026 (docket FDA-2012-N-1021).
Related
Sources
- FDA: discussion paper and request for feedback
- RAPS Regulatory Focus: CDRH FY2027 guidance agenda (Oct 2, 2026)
FAQ
Has FDA issued guidance on generative-AI medical devices?
Not yet. FDA's discussion paper on generative AI-enabled devices says it is for discussion only and is not draft or final guidance.
When are comments on FDA's generative-AI discussion paper due?
By October 19, 2026, under docket FDA-2026-N-7874 on Regulations.gov.
Is generative-AI guidance on CDRH's FY2027 list?
Yes. A draft guidance on generative AI-enabled conversational devices for mental health disorders is an A-list priority, and generative-AI risk assessment is in the lower-priority third tier, according to RAPS.