FDA generative-AI medical-device feedback closes October 19
FDA invites feedback on a discussion paper about risk assessment and oversight of generative-AI medical devices.
What the record says
FDA’s Digital Health Center of Excellence seeks input from manufacturers, clinicians, researchers and the public. Topics include risk assessment, premarket evaluation and postmarket monitoring. Comments may address selected questions relevant to the commenter’s expertise.
Source details and supporting locations.
Practical next step
Submit feedback through Regulations.gov under docket FDA-2026-N-7874 by October 19.
Limits and what is not established
The paper is for discussion and is neither draft nor final guidance. It does not itself implement policy changes or approve a device.
Sources checked October 15, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information