FDA acted properly and within its statutory authority when it reclassified ReGen Biologics Menaflex knee repair device and rescinded the company’s 510(k), a Washington DC federal judge ruled in April. The company filed a lawsuit in 2011 charging that FDA’s decision to withdraw the device’s clearance was arbitrary and capricious. CDRH cleared the device in 2008 over objections of some reviewers that it provided little or no benefit to patients. The new agency leadership brought in by the Obama administration reviewed the earlier decision and determined that the device should not have been cleared because FDA’s review was influenced by outside pressure, including congressional lobbying. Ivy Sports Medicine subsequently became the successor in interest to ReGen, according to the court.
Ivy argued that because the law provides a reclassification procedure that FDA did not use, the agency violated the law. The court, however, disagreed and sided with the agency’s argument that it properly used its inherent authority to reclassify the device.
Jim Dickinson writes the Washington Wrap-Up Column for MD+DI.