FDA Seeks Input on Oversight of Generative AI-Enabled Medical Devices

The FDA issued a discussion paper seeking public feedback on possible regulatory approaches for generative artificial intelligence (GenAI)-enabled medical devices. The agency is requesting comments on risk assessment, premarket evaluation, postmarket monitoring, foundation models, and agentic artificial intelligence systems.

The paper outlines a possible two-axis framework for assessing risk and informing regulatory expectations. For premarket evaluation, the FDA describes a competency-assessment approach inspired at a high level by physician training and evaluation. The approach would combine nonclinical device benchmarking with clinical confirmation to assess whether a device performs as intended before reaching patients.

The FDA also describes potential approaches to risk-proportionate postmarket monitoring. The agency said GenAI-enabled devices may introduce unique risks compared with traditional software and other artificial intelligence-enabled medical devices. The paper also addresses considerations related to foundation models and agentic systems.

The Digital Health Center of Excellence, within FDA’s Center for Devices and Radiological Health, is leading the initiative. The release presents the framework and evaluation methods as possible or potential approaches rather than announcing a final regulatory standard. FDA said its targeted questions are intended to inform the development of a scientifically rigorous framework that prioritizes patient safety and aligns with the novel capabilities of GenAI-enabled devices.

Device manufacturers, clinicians, researchers, consumers, members of the public, and other interested parties may submit comments under docket FDA-2026-N-7874 by October 19, 2026.

Source: US Food and Drug Administration. FDA seeks public feedback to inform regulatory approach for generative AI-enabled medical devices. News release. US Food and Drug Administration; August 18, 2026. Accessed August 20, 2026.