FDA Will Maintain AI Device Authority Following ONC Reorganization

By Jessica Karins / July 29, 2024 at 5:02 PM
HHS’ move to beef up the department’s oversight of artificial intelligence and health technology by setting up a new Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC) office will not impact the FDA device center’s regulation of AI-enabled medical devices, FDA told Inside Health Policy. “The responsible development of AI in health care is a central focus for regulators. CDRH maintains its authority and responsibility for assuring the safety and effectiveness...


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