FDA’s Center for Devices and Radiological Health (CDRH)

FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to modernize FDA’s 510(k) program

November 26, 2018 / FDA Statement Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety…