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Due Date Reminder: FDA Request for Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

The Digital Health Center of Excellence (DHCoE), within the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, is seeking feedback from device manufacturers, clinicians, researchers, the public, and other interested parties on questions posed in the discussion paper titled “Considerations for the Regulation of Generative AI-Enabled Medical Devices.”

Due Date for Feedback

Please submit feedback under docket number FDA-2026-N-7874 on Regulations.gov, by October 19, 2026.

Questions?

If you have questions about this communication, contact digitalhealth@fda.hhs.gov.