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

Discussion Paper Supports FDA’s Innovation and Global Leadership Strategic Pillar; Public Docket Opens on Regulations.gov

The U.S. Food and Drug Administration (FDA) today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to the regulation of GenAI-enabled medical devices.  This effort aligns with one of the Trump Administration’s key priorities to harness AI to accelerate the delivery of innovative medical products to market.

“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” said Acting FDA Commissioner Kyle Diamantas, J.D.  “Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”

The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health, is leading this discussion paper which supports the FDA’s Public Health Pillar on Innovation and Global Leadership.  This strategic pillar includes key priorities to advance regulatory frameworks for AI and digital health technologies.

“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D.  “By inviting input from the public, we are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation, and serves as a potential model for regulators around the world.”

GenAI‑enabled medical devices hold transformative promise for patient care and the broader health ecosystem.  At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.  This discussion paper is intended to engage stakeholders on the challenges associated with GenAI-enabled medical devices and ways to advance regulatory approaches for these devices.  The paper supports DHCoE’s efforts to advance health care by fostering innovation of safe, effective, and high-quality digital health technologies.

Submitting Feedback

DHCoE encourages feedback from device manufacturers, clinicians, researchers, the public, and other interested parties, to be submitted under docket number FDA-2026-N-7874 on Regulations.gov by October 19, 2026.

Questions?