FDA seeks public input on regulation of generative AI medical devices
The FDA is requesting public feedback on the regulation of generative AI-enabled medical devices, focusing on risk assessment, premarket evaluation, and post-market monitoring, with a deadline of October 19, 2026.
The U.S. Food and Drug Administration (FDA) is requesting feedback from the public regarding the regulation of generative artificial intelligence (GenAI)-enabled medical devices, according to an announcement.
Specifically, they are seeking feedback from device manufacturers, clinicians, consumers, researchers, the public, and other interested parties on:
Risk assessment
Premarket evaluation
Post-market monitoring
Other relevant topics
The agency’s Digital Health Center of Excellence (DHCoE) published a discussion paper on August 18, containing possibilities for the framework. Interested parties should review the discussion paper and provide feedback by October 19, 2026 under docket FDA-2026-N-7874.
