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ATA Action urges FDA to build risk-based framework for AI-enabled medical devices

October 26, 2026HME News Staff

WASHINGTON – ATA Action, the advocacy-focused affiliate of the American Telemedicine Association (ATA), has submitted comments in response to the U.S. Food and Drug Administration's discussion paper on AI-enabled medical devices, saying manufacturers should remain responsible for the safety and performances of the devices they sell. The organization says the FDA should avoid shifting monitoring duties to the small, rural and safety-net practices that lack the staff to take them on and...

American Telemedicine Association (ATA), artificial intelligence, Safety


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