BioCentury
ARTICLE | Company News

ReGen Biologics musculoskeletal news

June 6, 2011 7:00 AM UTC

ReGen filed suit against FDA in the U.S. District Court for the District of Columbia claiming that the agency's decision to reclassify ReGen's Menaflex collagen meniscus implant as a class III device from a class II device was "arbitrary, capricious, an abuse of discretion and not in accordance with law." ReGen claims that its bankruptcy was a direct result of FDA's decision and is seeking reclassification as a class II device and the ability to market Menaflex in the U.S. ...