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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

Original source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm