FDA Should Scrap Moderate-Risk Review Process: Report

Law360, New York (July 29, 2011, 2:03 PM EDT) -- The U.S. Food and Drug Administration's current process for approving moderate-risk medical devices fails to properly evaluate safety and effectiveness, and should be replaced with a new clearance program, the Institute of Medicine recommended in a report released Friday.

The FDA's review process for devices under Section 510(k) of the Federal Food, Drug and Cosmetic Act — which allows lower-risk Class II medical devices to be marketed if they are substantially equivalent to devices already on the market — relies too heavily on substantial equivalence, and...
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