A divided U.S. Court of Appeals for the D.C. Circuit has ordered the U.S. Food and Drug Administration to retract its decision to rescind approval for a medical device, ruling the agency lacked authority to undertake that action.
In December 2008, the FDA approved a surgical mesh device to be used in knee-replacement surgeries called Collagen Scaffold and made by New Jersey-based ReGen Biologics Inc. out of bovine collagen.
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