FDA asks how to regulate generative AI medical devices

The U.S. Food and Drug Administration asked for public comment on how to regulate generative-AI medical devices in a discussion paper, not draft or final guidance.

The U.S. device regulator put a named generative-AI framework question on a primary.gov page. Nothing here clears a product.

The FDA (U.S. Food and Drug Administration) said CDRH’s Digital Health Center of Excellence issued a discussion paper on regulating generative AI-enabled medical devices and asked for public comment. CDRH is the Center for Devices and Radiological Health, the device arm of the agency.

The paper floats a competency-style premarket idea — lab tests first, then a check in real care — 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 public comment deadline. The announcement is a request for feedback, not draft or final guidance.