On September 6, 2012, the United States Food and Drug Administration (FDA or “the Agency”) made available for comment its report “Strengthening Our National System for Medical Device Postmarket Surveillance.” 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 FDA “develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze, and act on medical device postmarket performance information.” In its report, FDA proposes four specific actions to strengthen the medical device postmarket system...
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