Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI September 3, 2026 By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2026/09/regulating-a-moving-target-fda-seeks-comments-on-possible-framework-for-regulation-of-genai/?utm_source=rss&utm_medium=rss&utm_campaign=regulating-a-moving-target-fda-seeks-comments-on-possible-framework-for-regulation-of-genai On August 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) released Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (Discussion Paper). The paper is not draft or final guidance; rather, it is intended to solicit feedback on the regulation of generative artificial intelligence (GenAI)-enabled medical devices. It poses 26 discussion questions in the categories of assessment of risk, a competency-based approach for premarket evaluation, postmarket monitoring, foundation model device master files, and considerations for agentic AI systems.