ARTICLE | Company News

FDA to rescind clearance for collagen implant

October 15, 2010 12:45 AM UTC

FDA said it will rescind marketing clearance for Menaflex collagen meniscus implant from ReGen Biologics Inc. (OTCBB:RGBO). In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue injuries. Last year, FDA released a report recommending a reevaluation of the approval of a 510(k) application for the resorbable collagen scaffold to re-grow meniscus cartilage because the review process had been influenced by outside pressures. FDA said a review of the application found that Menaflex is intended for different uses and is technologically dissimilar from already marketed "predicate" devices, and thus should not have been approved. ...