Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

https://www.fda.gov/medical-devices/digital-health-center-excellence/considerations-regulation-generative-ai-enabled-medical-devices-discussion-paper-and-request?utm_medium=email&utm_source=govdelivery 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.”