FDA Seeks Feedback on Regulating Generative AI Medical Devices

Generative artificial intelligence (AI) is rapidly entering clinical workflows, offering tools that could enhance patient care while introducing risks that differ from those of traditional software. Hospitals and clinicians therefore need clear expectations for assessing safety and performance both before and after deployment. As these technologies continue to evolve, a coordinated regulatory framework will be essential. A new discussion paper outlines potential approaches for regulating generative AI-enabled medical devices and invites public feedback.

On August 18, 2026, the U.S. Food and Drug Administration (FDA) issued a discussion paper seeking feedback on considerations for regulating generative AI (GenAI)-enabled medical devices. The document is led by the Digital Health Center of Excellence (DHCoE) within the Center for Devices and Radiological Health (CDRH) and supports the agency’s Innovation and Global Leadership strategic pillar. The paper invites comment on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to GenAI-enabled medical devices.

The paper proposes a possible two-axis framework for assessing risk and informing regulatory expectations. For premarket evaluation, it outlines a competency-based approach that draws broadly from physician training and combines non-clinical device benchmarking with clinical confirmation to verify performance before patient exposure. It also discusses risk-proportionate postmarket monitoring and addresses additional considerations for foundation models and agentic artificial intelligence systems.

To help shape a regulatory framework that is scientifically rigorous, prioritizes patient safety, and reflects the novel capabilities of GenAI-enabled devices, the agency poses targeted questions across each of these areas. Feedback is encouraged from device manufacturers, clinicians, consumers, researchers, the public, and other stakeholders. 

“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies. 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,” said Michelle Tarver, M.D., Ph.D., Direcotr of the FDA Center for Devices and Radiological Health.

“Generative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era. This discussion paper advances the frontiers of regulatory science and propels a critical conversation about how to enable beneficial innovation, protect public health, and preserve trust,” said DHCoE Director Rick Abramson, M.D.

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Digital Health Center of Excellence