September 29, 2014 by Brad Perriello
A federal appeals court vacates the FDA’s decision to rescind its 510(k) clearance for ReGen Biologics’ MenaFlex knee implant, ordering the watchdog agency to conduct “further proceedings.”
ReGen Biologics won a round in its long battle with the FDA over its MenaFlex knee implant last week when a federal appeals court vacated the watchdog agency’s move to rescind clearance for the collagen mesh implant and ordered “further proceedings” for the device.
The Hackensack, N.J.-based company declared bankruptcy in 2011, a year after the FDA’s Center for Devices & Radiological Health pulled its 510(k) clearance for the Menaflex device. ReGen sued in the U.S. District Court for the District of Columbia to overturn the rescission, calling it “arbitrary and capricious, an abuse of discretion, not in accordance with law, and in excess of statutory jurisdiction, authority and limitations.”
The district court disagreed in April 2013, granting the FDA’s motion to dismiss on the grounds that the federal watchdog agency was within its rights to turn its green light for Menaflex to red. ReGen’s bankruptcy successor, Ivy Sports Medicine, appealed to the U.S. Court of Appeals for the D.C. Circuit, arguing that the appeals court’s own precedent in another case, American Methyl and New Jersey, held that “when Congress has provided a mechanism capable of rectifying mistaken actions … it is not reasonable to infer authority to reconsider agency action,” according to court documents.
The D.C. Circuit appeals court agreed Sept. 26 in 2-1 decision, with the majority ruling that the FDA should have gone through the procedure established by Congress, according to court documents.
