ARTICLE SUMMARY:
FDA drafts mental health generative AI guidance. Excerpted from Pathways Picks October 7: AI Plans in the UK and US, Europe’s First JCA Devices, and More.
The agency center is working on a draft guidance promising evidentiary recommendations for generative AI-enabled “conversational devices for mental health disorders,” with hopes to publish by next September. It would be the agency’s first-ever guidance focused on generative AI, following a 2025 Digital Health Advisory Committee meeting on AI mental health devices and an August discussion paper proposing novel strategies for regulating generative AI. FDA has yet to authorize a generative AI mental health chatbot. However, two such products have been accepted into CDRH’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, where they can be used routinely as part of CMS’ ACCESS outcomes-based payment model for digital health-driven care, and generate real-world evidence to support authorization and likely inform the guidance development.
The pending generative AI document is the only new draft guidance on CDRH's top-priority “A-list" of proposed guidances for FY 2027. The list, released October 1, also suggests the center plans to finalize by next fall its guidance on “marketing submission and lifecycle management recommendations” for AI-enabled device software functions and its broader guidance (not limited to digital health) on PCCPs. The annual guidance list indicates how the device center plans to focus resources but it doesn’t guarantee timely publication. For instance, two out of four final guidances and three out of four draft guidances on the FY 2026 A-list have been published as of October 6.
Other non-AI guidance documents prioritized for this year include final guidelines on robotic surgery devices, addressing the Quality Management System Regulation in PMAs, as well as use of standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program. Next-level-down B-list guidances include an updated final guide on the Q-Submission Program and draft guidance on “postmarket management of cybersecurity in medical devices.”