The Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices.  The DHAC will discuss potential “benefits, risks to health, and risk mitigations” for such devices, “including premarket evidence and postmarket monitoring considerations.”

The DHAC, established in 2023 to advise FDA on emerging digital health technologies, last met in November 2024 to discuss total product lifecycle considerations for genAI-enabled medical devices.  The focus on mental health applications for this year’s meeting follows increasing attention on these issues at the state and federal level.  For example, several states – including Illinois, Utah, and Nevada – have enacted state laws restricting or placing parameters around the use of mental health/therapy chatbots, and regulators have been exercising increased attention on this topic. 

In the Federal Register notice, FDA states that mental health devices pose novel risks, and as they continue to evolve, regulatory approaches ideally also will evolve in a way that accommodates these novel challenges while promoting innovation.  The Agency also acknowledges in the notice that there is a growing demand for mental health services but insufficient access to qualified providers, and suggests these devices may be one way to address this gap in care. 

FDA is accepting written comments on the public docket through December 8, 2025.  Comments received on or before October 17, 2025 will be provided to the DHAC in advance of the meeting. 

Companies developing or marketing genAI-enabled technologies should monitor these proceedings and consider providing feedback to the Agency.  Please feel free to contact our Digital Health team for guidance on these issues.