FDA asks how to regulate generative AI medical devices

On 18 August 2026, the FDA asked for public comment on how to regulate generative-AI medical devices. This is a discussion paper, not draft or final guidance. The docket stays open through 19 October 2026.

18 Aug 2026: FDA said CDRH’s Digital Health Center of Excellence issued a discussion paper on regulating generative AI-enabled medical devices and asked for public comment.

The paper floats a competency-style premarket idea — non-clinical benchmarking plus clinical confirmation — and asks about risk assessment, postmarket monitoring, foundation models, and agentic systems.

FDA: comments go to docket FDA-2026-N-7874 on Regulations.gov by 19 Oct 2026. The announcement is a request for feedback, not draft or final guidance.

The U.S. device regulator put a dated GenAI framework question on a primary .gov page. Nothing here clears a product.