September 14, 2025

FDA Advisory Panel to Evaluate AI in Mental Health Devices on Nov 6

Beckers Hospital Review

Contributed by: Kate Gamble

Summary

The FDA's Digital Health Advisory Committee will convene on November 6 to discuss generative artificial intelligence applications in digital mental health devices, assessing their risks, benefits, and regulatory implications. This public meeting aims to gather input from stakeholders, with a deadline for written comments set for October 17, and a continuous feedback opportunity available until December 8. The committee will focus on both premarket evidence and postmarket monitoring strategies, emphasizing the growing importance of AI in healthcare technology. This engagement reflects a critical step in addressing regulatory challenges and safety concerns as the integration of AI into mental health solutions advances.