ReGen Biologics Inc. (OTC:RGBO) is firing back at the Food & Drug Administration after the federal watchdog agency said last week that it plans to rescind a 510(k) clearance for ReGen’s controversial Menaflex knee implant.

“For CDRH to arrive at the decision that the device has a new intended use four years after two senior CDRH officials informed the company that the device could be reviewed through the 510(k) program is totally unbelievable,” ReGen chairman and CEO Gerald Bisbee Jr. said in prepared remarks. “Even more incredible is that they arrived at that conclusion after the second Orthopedic Advisory Panel of independent experts chosen by FDA was specifically asked about the intended use of the device and confirmed that it functioned like predicates. When they received that answer from the panel, CDRH repeated the same question three additional times in order to try to get the answer that they apparently wanted, but they did not.”

The rescission means Hackensack, N.J.-based ReGen has to keep its Menaflex device off the U.S. 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,’" the agency said last week.

"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."

The FDA said 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," five years after the company began the 510(k) application process.

Bisbee said ReGen has sunk $30 million into meeting requirements set by the FDA’s Center for Devices & Radiological Health, "only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true.”

“The agency’s clearance of Menaflex has become a political football and the FDA is not playing by the rules," he said. "The Menaflex device has the potential to provide U.S. surgeons the same safe and effective treatment for patients with meniscus injury as European surgeons have experienced with thousands of patients over the last nine years. This sets the stage for an increased regulatory burden imposed by the FDA which will slow down or stall medical device innovation in the U.S. — traditionally a world leader. Already, we are seeing more and more medical device companies leave the U.S. to conduct clinical trials and market their products. Smaller companies with innovative products are not pursuing FDA clearance because of the unpredictability in regulation and increased regulatory burden.”

ReGen said is looking into "alternatives" to fund additional marketing for the device by its European subsidiary and is "evaluating its options in response to the FDA’s intention to rescind its U.S. clearance."

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.

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW