The U.S. Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will convene a virtual public meeting on November 6, 2025, to discuss and make recommendations on Generative Artificial Intelligence (GenAI)-Enabled Digital Mental Health Medical Devices.

This meeting is a critical step in establishing regulatory clarity for the rapidly emerging class of digital mental health tools, which include AI-powered chatbots and virtual therapists. The DHAC will specifically:

• Assess Benefits and Risks: Examine how these devices can help bridge the significant gap in mental health service access in the U.S., while also thoroughly probing the unique health risks they pose.
• Evaluate Regulatory Pathways: Discuss potential regulatory considerations, including the appropriate premarket evidence required for approval and strategies for effective postmarket monitoring.

The DHAC’s function is to provide expert advice to the FDA on digital health technology regulations, including AI/ML and digital therapeutics. The FDA is accepting public comment on this topic via docket number FDA-2025-N-2338 through December 8, 2025. Comments received by October 17, 2025, will be provided to the Committee ahead of the meeting.

Learn more on the FDA website here.