The U.S. Food and Drug Administration released a discussion paper seeking public input on how to regulate medical devices that use generative artificial intelligence, opening a docket through Oct. 19, 2026. The agency outlines a risk-based construct, proposes “competency” evaluations that include nonclinical benchmarking and clinical confirmation before clearance, and sketches approaches for proportional postmarket surveillance. The paper also addresses oversight questions for foundation models and agentic AI systems.
The initiative, led by the FDA’s Digital Health Center of Excellence, is part of a broader push to modernize digital health regulation. Clearer guardrails could speed innovation for device makers and hospitals while tightening expectations around evidence, monitoring, and trust in AI-driven tools used in patient care.
Related articles:
— NIST AI Risk Management Framework 1.0
— WHO Guidance on Ethics and Governance of AI for Health
