FDA To Yank Marketing Approval For Menaflex Device

Law360, New York (October 14, 2010, 7:20 PM EDT) -- The U.S. Food and Drug Administration revealed Thursday that it is planning to rescind its erroneous marketing clearance for a ReGen Biologics Inc. knee device, following the release of a report finding that the approval was compromised by Capitol Hill pressure and a lack of safety data.

ReGen's Menaflex Collagen Scaffold device should never have been cleared by the FDA in December 2008 for the repair and reinforcement of the meniscal tissue in the knee, the regulator admitted in a press release.

The agency reached this...
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