GAO Calls For Reforms In FDA Oversight Of Device Recalls
This article was originally published in The Gray Sheet
Executive SummaryThe Government Accountability Office is urging FDA to clarify and strengthen its oversight of medical device recalls.
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Report again calls for improvement in oversight of medical device recalls by FDA, as well as for increased inspections of foreign establishments that make medical products for the U.S. market.
Details on draft legislation circulating in the House and Senate.
ORA sets a 2012 priority of improving the efficiency of the recall process to help reach its overall enforcement and compliance goal of preventing public health emergencies.