WASHINGTON, D.C. — The Food and Drug Administration last week proposed a potential regulatory framework for medical devices powered by generative artificial intelligence, opening scrutiny of how manufacturers assess safety, demonstrate clinical performance and monitor products after they reach patients.
A discussion paper released by the agency outlines possible requirements spanning risk classification, premarket evaluation and postmarket surveillance. The FDA is accepting public feedback through October 19, 2026.
The initiative could shape the standards companies must satisfy when developing medical devices that generate outputs using artificial intelligence, including systems built on foundation models and agentic AI technologies.
The agency identified potential risks associated with generative AI that differ from those presented by conventional medical software and other AI-enabled devices.
Its discussion paper describes a possible two-axis framework for assessing risk and determining the level of regulatory scrutiny appropriate for individual products.
For premarket review, the FDA is considering a competency-based assessment modeled broadly on how physicians are trained and evaluated.
That approach would combine nonclinical benchmarking with clinical confirmation to determine whether devices perform as intended before they are used in patient care.
The agency also outlined potential monitoring requirements after devices enter the market, with oversight calibrated to the risks associated with particular products.
Additional sections address foundation models and agentic AI systems, technologies that may require distinct regulatory considerations because of their capabilities and potential applications.
“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated.
The center’s Digital Health Center of Excellence is leading the initiative, which the agency described as an effort to update regulatory frameworks for artificial intelligence and digital health products.
Device manufacturers, clinicians, researchers, consumers and other interested parties can submit comments through Regulations.gov under docket FDA-2026-N-7874.
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