Federal Court Of Appeals Holds FDA Lacks Authority To Rescind 510(k) Clearance

The U.S. Court of Appeals for the District of Columbia recently held that the FDA lacks the authority to rescind a 510(k) clearance. In Ivy Sports Medicine, LLC v. Burwell, Case No. 13-5139 (Sept. 26, 2014 D.C. Cir), the court reversed a contrary decision by the district court and ordered the district court to vacate the FDA's decision and remand to the FDA for further proceedings.

The case originally involved a company named ReGen Biologics. In 1993 (twenty years ago!), ReGen began research on a new device for use in certain knee-repair surgeries and eventually developed a product called the Collagen Scaffold. The Collagen Scaffold is a crescent-shaped surgical mesh made of bovine collagen. According to ReGen, the Collagen Scaffold was intended to reinforce and repair the knee cartilage remaining after knee surgery and to provide a scaffold on which new tissue could grow.

ReGen originally submitted a pre-market approval (PMA) application for the Collagen Scaffold, but withdrew it. ReGen submitted two...