FDA makes ReGen 510(k) rescission final

FDA makes ReGen 510(k) rescission final

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ReGen Biologics Inc. reiterates its plan to seek regulatory and legal options for marketing its Menaflex knee implant, which the Food & Drug Administration forced off the market by rescinding its 510(k) clearance.

ReGen Biologics Inc. (OTC:RGBO) is weighing options for the Menaflex knee implant the FDA forced off the market last week.

The agency rescinded its 2008 510(k) clearance for the Hackensack, N.J.-based company’s embattled bio-absorbable knee implant last October. Last month ReGen rebuffed an offer from the FDA for a final hearing on the decision.

CEO Gerald Bisbee, never one to mince words, called the FDA’s rescission notice “totally unbelievable.” The company filed a statement with the Securities & Exchange Commission last week saying it was “evaluating its legal and regulatory options toward marketing the device in the United States.”

ReGen pulled the Menaflex immediately after the FDA’s formal rescission order and said the device will remain off the shelves until the federal watchdog agency clears a new marketing application or issues a reclassification of the device, according to the SEC filing.

The company did not specify what its legal options were.

“We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage,” Bisbee said in a March statement on his company’s refusal of a final FDA hearing.

“After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA’s administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients.”

The Menaflex 510(k) clearance in December 2008 came 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 Orthopedic & Rehabilitation Devices Panel 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.

CEO Gerald Bisbee, never one to mince words, called the FDA’s rescission notice “totally unbelievable.” The company filed a statement with the Securities & Exchange Commission last week saying it was “evaluating its legal and regulatory options toward marketing the device in the United States.”

ReGen pulled the Menaflex immediately after the FDA’s formal rescission order and said the device will remain off the shelves until the federal watchdog agency clears a new marketing application or issues a reclassification of the device, according to the SEC filing.

The company did not specify what its legal options were.

“We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage,” Bisbee said in a March statement on his company’s refusal of a final FDA hearing.

“After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA’s administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients.”

The Menaflex 510(k) clearance in December 2008 came 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 Orthopedic & Rehabilitation Devices Panel 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.

 

Full Article: http://www.massdevice.com/news/fda-makes-regen-510k-rescission-final

 

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