The U.S. Food and Drug Administration has issued a discussion paper on considerations for regulating generative artificial intelligence-enabled medical devices, according to the FDA.

The paper seeks feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics related to GenAI-enabled medical devices. The effort aligns with one of the Trump administration’s stated 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.”

Regulatory Framework for GenAI Devices

The discussion paper is being led by the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health. The effort supports the FDA’s Public Health Pillar on Innovation and Global Leadership, which includes 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.”

The FDA said GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem, while also introducing risks that may differ from traditional software and AI-enabled medical devices.