The U.S. Food and Drug Administration (FDA) has issued a discussion paper seeking public feedback on considerations for regulating generative AI (GenAI)-enabled medical devices.
The paper covers risk assessment, pre-market evaluation, post-market monitoring, and considerations around foundation models and agentic AI systems.
It outlines a possible two-axis framework for risk assessment and proposes a premarket evaluation approach based on competency assessment, including non-clinical device benchmarking and clinical confirmation. The paper also describes potential approaches to risk-proportionate post-market monitoring.
The FDA's Digital Health Center of Excellence within the Center for Devices and Radiological Health issued the paper. The FDA is seeking feedback from device manufacturers, clinicians, researchers, and the public through docket FDA-2026-N-7874 on Regulations.gov by October 19.
Read the full discussion paper here.
