ReGen Biologics asks a federal appeals court to overturn its loss of a lawsuit filed against the FDA over its Menaflex device, arguing that the federal watchdog agency lacked the authority to rescind its clearance of the knee implant.
ReGen Biologics' long battle against the FDA entered a new phase this year, with the medical device company's appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA's decision to rescind the clearance granted to ReGen's Menaflex knee implant.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1qrEuP5
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