 
The U.S. Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee. The Committee advises the Commissioner of Food and Drugs on issues related to digital health technologies, providing relevant expertise and perspective to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with the use of these technologies.
On November 6, 2025, the FDA plans to hold the Digital Health Advisory Committee meeting virtually from 9:00 a.m. to 6:00 p.m. ET. The Committee will discuss and make recommendations on the topic of generative artificial intelligence-enabled digital mental health medical devices. Many of these medical devices pose novel risks. As mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges and opportunities to provide a reasonable assurance of their safety and effectiveness while promoting innovation to support public health. The Committee will discuss the benefits, risks to health, and risk mitigations that might be considered for these new digital mental health devices, including premarket evidence and postmarket monitoring considerations.
The meeting will be open to the public. The FDA is establishing a docket for public comment. Registration is not required to attend the meeting.
Important Participation Due Dates:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee.
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October 9, 2025: Email Letise.Williams@fda.hhs.gov to request to make oral presentations during the public comment session of the meeting.
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October 17, 2025: Submit written comments on the public docket (FDA-2025-N-2338) to be reviewed by the Committee prior to the meeting.
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October 30, 2025: Request special accommodations for the meeting.
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December 8, 2025: Submit written comments to the docket for review and consideration by the FDA.
Questions?
If you have questions about this communication, contact digitalhealth@fda.hhs.gov.
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