The US Food and Drug Administration's procedures for overseeing medical device recalls are unclear and represent a missed opportunity for the agency to proactively identify and address risks presented by unsafe devices, the Government Accountability Office has said in a report1.
Gaps in the medical device recall process limit the ability of firms and the FDA to ensure that the highest-risk recalls were implemented in an effective and timely manner, said the GAO report, which examined information on 3,510 medical device recalls initiated and reported to the FDA from 2005 through 2009...
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