FDA Needs System to Monitor Safety of Medical Devices on the Market
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July 18 -- The U.S. Food and Drug Administration lacks effective procedures to monitor safety studies that manufacturers are sometimes required to undertake when they put medical devices on the market, says a new report from the Institute of Medicine that specifically examines FDA's surveillance of medical devices used with children. Congress should ensure that the agency establishes a reliable system to track these postmarket studies and that key information about these studies is made public.
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