FDA Seeks Input on Assessing Real-World Performance of AI Devices

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FDA Seeks Input From Public on How To Evaluate Real-World Performance of AI-Enabled Medical Devices

Agency Notes Value of ‘Ongoing, Systematic Performance Monitoring’ Over ‘Static Benchmarks’

Dennis Tosh

October 2, 2025 at 11:28 AM EST

The FDA is asking interested parties as well as the general public to submit to the agency information on best practices, methodologies and approaches for measuring and evaluating the real-world performance of artificial intelligence (AI)-enabled medical devices. Among the information sought are “approaches to detect, assess and mitigate performance changes over time to help ... Read More

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FDA Seeks Input From Public on How To Evaluate Real-World Performance of AI-Enabled Medical Devices

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