FDA 510(k) Rescission Authority Upheld - U.S. District Court Finds for FDA in ReGen Litigation


The United States District Court for the District of Columbia issued an opinion in Ivy Sports Medicine, Inc. v. Sebelius, a lawsuit filed in May 2011 by ReGen Biologics, Inc. (“ReGen”) against the Food and Drug Administration (FDA or “the Agency”) and decided on April 10, 2013. (Ivy Sports Medicine, Inc. (“Ivy”) acquired ReGen in June 2011.) The recent ruling is the latest event in ReGen’s attempt to reinstate the December 18, 2008, 510(k) clearance for its Menaflex collagen scaffold device that FDA rescinded on March 30, 2011. Although the ruling appears limited in its precedential value, it provides support for FDA’s long-held position that it has the inherent authority to rescind 510(k) clearances.

Background -

FDA rejected ReGen’s first two 510(k) notices for the Menaflex device, filed in July and December 2006, when the Agency determined that the device was not substantially equivalent to the claimed predicate devices. ReGen submitted a third 510(k) for the device in July 2008 and spoke with FDA officials in August 2008 following the lead reviewer’s recommendation that the Menaflex be found not substantially equivalent. Following a meeting of the Advisory Panel, ReGen’s Menaflex device finally gained FDA clearance in December 2008 as a Class II medical device. The device’s indications for use statement noted that the Menaflex was “intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the meniscus” in the knee...

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