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Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation

The FDA’s focus on both safety and innovation stems from our historic mission to protect and promote public health—to assure that medical devices on the U.S. market are high-quality, safe and effective and to facilitate innovation and assure that patients and...