ReGen Sues FDA Over Menaflex Clearance Repeal

Law360, New York (June 1, 2011, 5:02 PM EDT) -- ReGen Biologics Inc. sued the U.S. Food and Drug Administration in Washington on Tuesday, alleging that the agency's rescission of marketing clearance for its Menaflex collagen meniscus implant was unlawful and ultimately forced the company into bankruptcy.

The FDA originally classified the Menaflex device — used for the repair and reinforcement of the meniscal tissue in the knee — as a Class II device under the Federal Food, Drug, and Cosmetic Act in December 2008, after concluding that it was substantially equivalent to other legally marketed...
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