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Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on con

Monday, April 15, 2019  

One of the touchstones of medical device safety lies in the authority of the U.S. Food and Drug Administration to order manufacturers to conduct postmarket surveillance studies to address a new and significant health concern. Such studies yield important information that often lead to a broader understanding about a device’s risks and prompt the agency to issue new recommendations or policies to mitigate those risks.


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