The FDA will convene its Digital Health Advisory Committee Nov. 6 to discuss the use of generative artificial intelligence-based digital mental health medical devices.
The virtual meeting, scheduled from 9 a.m. to 6 p.m. Eastern time, will be open to the public. The committee will assess the risks, benefits and regulatory considerations surrounding emerging mental health technologies that incorporate generative AI — including premarket evidence and postmarket monitoring strategies — according to a Sept. 12 notice.
A public docket for written comments is open under docket number FDA-2025-N-2338. Comments submitted by Oct. 17 will be shared with the committee ahead of the meeting, and the docket will close Dec. 8.
The meeting will be held via an online teleconferencing platform and will include public presentations from approximately 10:30 a.m. to 12:30 p.m. Eastern time.
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