FDA Seeks Information on Measuring and Evaluating Performance of AI-enabled Medical Devices in the Real-World

The U.S. Food and Drug Administration (FDA) announces a “Request For Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World.”  This request builds on insights discussed during the FDA Digital Health Advisory Committee meeting in November 2024, where interested parties discussed robust real-world evaluation strategies to assure that artificial intelligence (AI)-enabled medical devices continue to be safe and effective after deployment.  AI, including generative AI, presents opportunities to improve patient outcomes, advance public health, and accelerate medical innovation.  At the same time, these technologies introduce new considerations as it relates to assuring the maintained safety and effectiveness of AI-enabled medical devices across the total product life cycle, and particularly with respect to assessing their performance, safety, and reliability after deployment in real-world settings.  The FDA is seeking information from interested parties and the public on best practices, methodologies, and approaches for measuring and evaluating real-world performance of AI-enabled medical devices.  This includes approaches to detect, assess, and mitigate performance changes over time to help assure these medical devices remain safe and effective throughout their life cycle.

Submitting Comments

Please submit all public comments to the docket (FDA-2025-N-4203), available at Regulations.gov.  The public comment period will end on December 1, 2025.

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