November 6, 2025: Digital Health Advisory Committee Meeting Announcement November 6, 2025

https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2025-digital-health-advisory-committee-meeting-announcement-11062025?utm_medium=email&utm_source=govdelivery Meeting Materials and Due Date Reminders: Digital Health Advisory Committee Meeting On November 6, 2025, the Digital Health Advisory Committee will discuss and make recommendations on the topic of generative artificial intelligence-enabled digital mental health medical devices. 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 post-market monitoring considerations. The meeting is open to the public. Registration is not required to attend. The FDA has now made available the following meeting materials: Agenda for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189389/download?attachment=&utm_medium=email&utm_source=govdelivery Roster for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189390/download?attachment=&utm_medium=email&utm_source=govdelivery Executive Summary for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189391/download?attachment=&utm_medium=email&utm_source=govdelivery FDA Discussion Questions for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189392/download?attachment=&utm_medium=email&utm_source=govdelivery Meeting date and time: November 6, 2025, from 9:00 a.m. to 6:00 p.m. Eastern Time Location: The advisory committee meeting will be held virtually. The meeting will be heard, viewed, captioned, and recorded for through an online teleconferencing and/or video conferencing platform.