The FDA has sought to revoke their approval of the Menaflex knee device relative to the fast track 501k approval process. ReGen states that the FDA has not given the company a fair and impartial review and thus continues to state that it’s just too costly and maybe a futile effort for them.
There’s a bit of history here and the product was approved during a prior administration. An internal probe found that ReGen executives had unusual access to von Eschenbach and approval came after von Eschenbach met several times with members of the New Jersey congressional delegation. In December, von Eschenbach approved the company's application without any explanation for overruling the judgment of his staff. Also, right around the time all of this erupted, the head medical device regulator left for a job at Microsoft. BD
FDA Medical-Device Regulator Leaves to Take Position at Microsoft Health Solutions Group – Director of Regulations and Policy
WASHINGTON -- In an unusual move, the maker of a knee device has declined an offer by the FDA for a hearing on the agency's effort to rescind approval of the product.
ReGen Biologics CEO Gerald E. Bisbee Jr., PhD, responding to a Jan. 21 letter from the FDA offering the hearing, said his company "believes that ... any [such] hearing ... would be a costly and futile exercise ... ReGen has no interest in continuing to be a pawn in bureaucratic infighting aimed at reforming the FDA's 510(k) review process."
Last October, the agency said it should not have approved the company's collagen-based knee implant, called Menaflex, under the 510(k) process and would seek to revoke the product's clearance after meeting with its manufacturer.
"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," according to the FDA.