FDA to Rescind Market Clearance for ReGen's Menaflex
BY LAUREN UZDIENSKI, OCTOBER 15, 2010
Conceding that the agency succumbed to political pressure during their Menaflex review, the FDA has decided to rescind ReGen's market clearance for the collagen-based meniscal device. This decision is unprecedented, with the New York Times noting that this is the first time the agency publicly admitted to wrongly approving a drug or device or that outside pressures influenced their review process. Menaflex will be the FDA's first rescission.
A year ago, an internal FDA investigation found several deviations from the prescribed 510(k) process, among them allegations that ReGen unfairly influenced their own review panel. That process review sparked a new scientific review of the device, which resulted in yesterday's announcement and determination that the Menaflex was not substantially equivalent to predicate devices.
The next step for the FDA is to issue a rescission notice, at which point ReGen can challenge the notice at a regulatory hearing or voluntarily withdraw their marketing clearance. The Times quoted ReGen Chairman and CEO Gerald Bisbee as saying the company was "weighing its options." Menaflex can remain on the market until the agency officially rescinds clearance.
The FDA also plans to meet with ReGen to discuss "what data it would need to provide a reasonable assurance of safety and effectiveness." Back in March, a CDRH panel concluded that the device was "likely safe."
