AI regulation

FDA Publishes Discussion Paper on Regulating Generative AI-Enabled Med Devices

The FDA has opened a discussion on how generative AI-enabled medical devices should be assessed, evaluated, and monitored. The paper raises pointed questions for manufacturers about risk, premarket review, and postmarket performance of these emerging devices.

EU Commission Issues Draft Guidelines for AI Systems

The EU Commission is seeking public comment on draft guidelines designed to help providers and deployers determine whether their AI system qualifies as high-risk under the AI Act — with the comment period open through June 23, 2026.

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