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FDA seeks feedback on measuring AI-enabled medical device performance
Summary by American Hospital Association
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FDA seeks feedback on measuring AI-enabled medical device performance
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device performance in real-world applications. This includes approaches to detect, assess and mitigate performance changes over time to help assure the devices remain safe and effective throughout their life cycle. The FDA is accepting comments at www.regulations.go…
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