FDA Continues Focus on AI Fronts, Seeks Public Comment on Measuring and Evaluating AI-enabled Medical Device Performance in the Real-World
October 9, 2025 Artificial Intelligence, Health Information Privacy & Security, AI/ML Devices, Health & Human Services (HHS), Digital Health, Healthcare Innovations
On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled medical devices. Specifically, FDA is seeking feedback on best practices, methodologies and approaches for measuring and evaluating real-world performance of AI-enabled medical devices from the public.
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