FDA seeks public input on regulating generative AI medical devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper seeking public input on the regulatory oversight of generative artificial intelligence (GenAI)-enabled medical devices. The document, issued by the Digital Health Center of Excellence within the Center for Devices and Radiological Health, aims to explore how the agency should approach technologies that include conversational interfaces, foundation models, and agentic workflows.

Unlike traditional software with predictable outputs, GenAI-enabled tools may accept open-ended inputs and generate varying responses to similar prompts, presenting unique challenges for risk assessment, evidence, and monitoring. Acting FDA Commissioner Kyle Diamantas stated that the agency seeks to ensure the United States leads in shaping the safe and responsible development of these technologies.

FDA officials emphasized that the paper is intended for discussion purposes and does not constitute formal policy or final regulatory guidance. The agency is inviting feedback from manufacturers, clinicians, researchers, and the general public through October 19 to help inform a regulatory approach that balances innovation with patient safety.