The FDA published a discussion paper this week seeking feedback on its considerations for regulations of GenAI-enabled medical devices.
One potential consideration in particular is catching attention: a “competency-based approach for premarket evaluation.
“GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem,” the FDA said in a news release. “At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.”
The paper outlines a possible framework for risk assessment, potential approaches to premarket evaluation and several possible approaches to risk-proportionate postmarket monitoring.
“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” FDA Center for Devices and Radiological Health Director Dr. Michelle Tarver said. “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.”
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CDRH is considering a competency-based evaluation of GenAI-enabled devices inspired by “at a high level, how human clinicians are evaluated and credentialed.”
“Clinicians, as well as GenAI-enabled devices, can ingest broad and varied information and can produce open-ended responses across a wide range of situations,” the agency said in the paper.
Device benchmarking would assess the product’s “clinical knowledge, analytic capabilities, safety behavior, communication, and generalizability to support reasonable assurance of safety and effectiveness of the device for its intended use,” FDA said.
The agency acknowledged that benchmark testing may not fully capture how a GenAI-enabled device would perform in real clinical practice. It’s considering clinical confirmation testing to gather evidence of the device’s performance in real clinical settings.
Some of FDA’s clinical confirmation ideas include standardized patient interactions with trained patient actors who would present as patients, a prospective clinical study and shadow deployment.
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CDRH said its “ultimate goal is to enable a nimble regulatory approach that employs least burdensome principles and allows patients timely access to safe and effective medical devices.”
“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” acting FDA Commissioner Kyle Diamantas, J.D. said. “[This] announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”
The discussion paper isn’t intended to represent a draft, final guidance, or propose policy changes; rather, it is published for discussion purposes only. The FDA is accepting feedback from device manufacturers, clinicians, researchers and the public until Oct. 19, 2026.
