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Request for Comments: AI-Enabled Medical Devices

Summary by FDA Law Blog
By Jennifer D. Newberger —On September 30, 2025, FDA released a Request for Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World. Comments are due to the docket by December 1, 2025. The request for comments is to obtain feedback about the “current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world, including strategies …
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FDA Law BlogFDA Law Blog

Request for Comments: AI-Enabled Medical Devices

By Jennifer D. Newberger —On September 30, 2025, FDA released a Request for Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World. Comments are due to the docket by December 1, 2025. The request for comments is to obtain feedback about the “current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world, including strategies …

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FDA Law Blog broke the news in on Friday, October 3, 2025.
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