12 Sep 2025
🧠FDA Meeting
Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices
Summary
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. The meeting will be open to the public. FDA is establishing a docket for public comment.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text outlines a public meeting on generative AI-enabled mental health devices, indicating a shift towards regulatory evaluations of new tech in healthcare. This meeting invites industry stakeholders to provide input, directly affecting compliance and potential market opportunities for businesses involved in digital health.