The Food & Drug Administration decided it was wrong to clear a knee implant made by ReGen Biologics Inc. (OTC:RGBO) in 2008, over-riding the objections of FDA reviewers.
The rescission means Hackensack, N.J.-based ReGen has to keep its Menaflex device off the market until it can prove its safety and effectiveness to the FDA’s satisfaction.
"The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called ‘predicate devices,’" according to a press release. "These differences can affect the safety and effectiveness of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency."
But before the federal watchdog agency rescinds the clearance, it wants ReGen to "discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness."
The Menaflex 510(k) clearance in December 2008 came despite the fact that the device often failed and required second operations — and over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.
In March, the agency’s Orthopaedic and Rehabilitation Devices Panel at the Center for Devices and Radiological Health decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying Regen failed to produce adequate evidence that device was safe before it was cleared to hit the market.