The U.S. Food and Drug Administration (FDA) has issued a new discussion paper seeking public feedback on how generative artificial intelligence (GenAI)-enabled medical devices should be evaluated and regulated. The initiative was announced on August 18, 2026, and is being led by the FDA’s Digital Health Center of Excellence within the Center for Devices and Radiological Health.
The agency is seeking input on several areas, including risk assessment, premarket evaluation, postmarket monitoring, foundation models, and agentic AI systems. According to the FDA, GenAI-enabled devices may offer significant opportunities for healthcare while introducing risks that differ from those associated with traditional software and existing AI-enabled medical devices.
Among the approaches outlined in the discussion paper is a possible two-axis framework for assessing risk. The FDA also discusses a potential premarket evaluation model based on “competency assessment,” combining non-clinical device benchmarking with clinical confirmation to determine whether a GenAI-enabled medical device performs as intended before reaching patients. The paper also considers risk-proportionate approaches to monitoring devices after they enter clinical use.
Kyle Diamantas, JD, Acting FDA Commissioner, said in the announcement:
“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly.”
The FDA emphasized that the publication is intended for discussion purposes only and does not represent draft or final guidance. It does not establish new regulatory expectations or implement changes to the FDA’s current approach to GenAI-enabled medical devices.
The agency is inviting feedback from medical device manufacturers, clinicians, researchers, consumers, and other interested stakeholders. Comments can be submitted under docket FDA-2026-N-7874 through October 19, 2026.
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