IOM Recommends Elimination Of 510(k) Process
Mondaq Business Briefing › United States Law Articles in English (2011)
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IOM Recommends Elimination Of 510(k) Process
Consequences for the Defense Bar
At the direction of the Food and Drug Administration (FDA), the Institute of Medicine (IOM)1 recently reviewed the 510(k) clearance process for medical devices. On July 29, 2011, after a 16-month review, the IOM released its much-anticipated report titled Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years (the "Report"), and called for the elimination of the 510(k) clearance process. This article examines the conclusions and recommendations of the Report and the process by which the IOM arrived at its conclusions. While recognizing that the Plaintiffs' bar will attempt to use the Rep...See the full content of this document
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