FDA Digital Health Advisory Committee Meeting

‘U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Digital Health Advisory Committee (DHAC) Meeting “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices.”’

Agenda:

November 6, 2025 FDA Perspective: Generative Artificial Intelligence-Enabled (GenAI) Digital Mental Health Medical Devices FDA Perspective: Regulatory Considerations for Digital Mental Health Therapeutics

• Topic 1: Large Language Models in digital mental health medical devices
• Topic 2: The impact of GenAI on digital mental health medical devices development
• Topic 3: Developer Perspective on GenAI digital mental health medical devices
• Topic 4: Clinical trial evaluation of GenAI digital mental health medical devices
• Topic 5: Best practices and lessons learned from other fields of AI
• Topic 6: Patient-provider considerations in the use of GenAI-enabled digital mental health medical devices
• Topic 7: Payer perspectives on digital mental health technologies
• Topic 8: Health technology assessment perspective of GenAI digital mental health medical devices Committee Discussion of the FDA
• Questions
• Closing Remarks
• Adjourn