The US Food and Drug Administration (FDA) has issued a discussion paper seeking public feedback on potential regulatory considerations for generative artificial intelligence (GenAI)-enabled medical devices. The initiative examines how regulators can assess the safety and effectiveness of medical devices incorporating rapidly evolving generative AI technologies.

The discussion paper seeks input on several areas, including risk assessment, premarket evaluation, postmarket monitoring, foundation models and agentic AI systems. The FDA said the initiative is intended to support responsible innovation while ensuring that emerging technologies meet appropriate standards for patient safety and performance.

The effort is being led by the Digital Health Center of Excellence (DHCoE) within the FDA’s Center for Devices and Radiological Health (CDRH). It forms part of the agency’s broader focus on developing regulatory frameworks for artificial intelligence and digital health technologies.

Acting FDA Commissioner Kyle Diamantas said artificial intelligence is transforming medicine and emphasised the importance of ensuring that the US plays a leading role in shaping how the technology is developed and deployed safely and responsibly.

The FDA noted that GenAI-enabled medical devices could significantly transform patient care and the broader healthcare ecosystem, while also presenting risks that may differ from those associated with conventional software and existing AI-enabled medical devices.

The discussion paper proposes a potential two-axis framework for risk assessment that could help determine appropriate regulatory expectations for different GenAI-enabled medical devices. The agency is seeking feedback on whether such an approach could effectively account for the varying risks and capabilities of these technologies.

For premarket evaluation, the FDA outlines a potential competency assessment approach. Drawing broadly on the way physicians are trained and evaluated, the proposed framework would combine non-clinical device benchmarking with clinical confirmation to assess whether a GenAI-enabled medical device performs as intended before being used on patients.

The paper also considers potential risk-proportionate postmarket monitoring strategies, recognising that the performance and behaviour of GenAI systems may evolve over time. Additional considerations are outlined for foundation models and agentic AI systems, which can introduce different levels of autonomy and complexity into medical applications.

For each area covered in the discussion paper, the FDA has posed targeted questions to stakeholders. The agency said feedback will help inform the development of a regulatory framework that is scientifically rigorous, proportionate to risk and responsive to the capabilities of GenAI-enabled medical devices.

The FDA is inviting medical device manufacturers, healthcare professionals, consumers, researchers and other interested parties to submit comments on the discussion paper. Feedback should be submitted under docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026.

The initiative reflects the FDA’s broader efforts to establish regulatory approaches for emerging digital health technologies while encouraging the development of safe, effective and high-quality medical innovations.