Strengthening Medical Device Postmarket Surveillance

Law360, New York (October 3, 2012, 1:53 PM EDT) -- On Sept. 6, 2012, the U.S. Food and Drug Administration made available for comment its report “Strengthening Our National System for Medical Device Postmarket Surveillance.”[1] The report provides the agency’s proposals to strengthen the medical device postmarket surveillance system in the United States.

In July 2011, the Institute of Medicine (“IOM”) published a report entitled, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” IOM’s report recommended that the FDA “develop and implement a comprehensive medical device postmarket surveillance strategy to...
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