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Event Home

Nov 9, 2025

Nov 9, 2025

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FDA Digital Health Advisory Committee Meeting

*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.

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‘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

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