FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

The U.S. Food and Drug Administration has released a discussion paper outlining potential regulatory approaches for generative AI-enabled medical devices, covering risk assessment, premarket evaluation, and postmarket monitoring. The agency is inviting comments from manufacturers, clinicians, researchers, and the public via a dedicated docket through October 19, 2026, signaling a major step toward formal clinical AI standards and governance in the U.S.