Considerations For The Regulation Of Generative AI-Enabled Medical Devices: Discussion Paper & Request For Feedback

In August 2026, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) published a discussion paper to engage stakeholders on Generative artificial intelligence (GenAI)‑enabled medical devices and to solicit feedback on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to the regulation of GenAI-enabled devices . . .