FDA Seeks Feedback on AI-Enabled Devices
The FDA has issued a discussion paper on regulating generative AI-enabled medical devices, seeking public feedback on risk assessment and evaluation
The U.S. Food and Drug Administration is seeking public feedback on a discussion paper regarding the regulation of generative artificial intelligence (GenAI)-enabled medical devices. According to Acting FDA Commissioner Kyle Diamantas, J.D., the FDA aims to advance innovation for health care professionals and leverage AI to improve care and patient health outcomes.
The discussion paper, led by the Digital Health Center of Excellence, supports the FDA's Public Health Pillar on Innovation and Global Leadership. FDA Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. stated that patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies.
Background
The FDA's effort to regulate GenAI-enabled medical devices is part of its strategic pillar to advance regulatory frameworks for AI and digital health technologies. GenAI-enabled medical devices hold transformative promise for patient care, but may also introduce unique risks compared to traditional software and AI-enabled medical devices.
Regulatory Approach
The discussion paper outlines a possible two-axis framework for risk assessment and discusses a potential approach to premarket evaluation built on the concept of competency assessment. The paper also describes several potential approaches to risk-proportionate postmarket monitoring and discusses considerations around foundation models and agentic AI systems. The FDA poses targeted questions to inform the development of a regulatory framework that is scientifically rigorous and prioritizes patient safety.
Feedback and Next Steps
The FDA encourages feedback on the discussion paper from device manufacturers, clinicians, consumers, researchers, and other interested parties. Feedback can be submitted under the docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026. The FDA's goal is to advance health care by fostering the responsible innovation of safe, effective, and high-quality digital health technologies.
The FDA, as reported in the discussion paper, is taking a transparent approach to inform the development of a regulatory framework for GenAI-enabled medical devices. As stated by DHCoE Director Rick Abramson, M.D., this discussion paper advances the frontiers of regulatory science and propels a critical conversation about how to enable beneficial innovation and protect public health.
