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Home » ReGen Biologics Sues FDA Over Rescinded 510(k)
ReGen Biologics Sues FDA Over Rescinded 510(k)
June 3, 2011
ReGen Biologics is filing suit against the FDA, alleging the agency has exceeded its statutory and regulatory authority in rescinding the 510(k) for ReGen’s Menaflex Collagen Meniscus Implant (CMI).