The FDA has announced that an orthopedic device for the knee made by ReGen Biologics shouldn't have been cleared for marketing. The announcement follows a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the review of the device.
After implementing a rescission, the FDA prohibits the manufacturer from further U.S. marketing until the agency approves or clears a new marketing application, or grants a classification petition. The manufacturer then has the option of requesting a regulatory hearing with the FDA or can choose to voluntarily withdraw their marketing clearance. The device will remain on the market until the agency rescinds its clearance.
The FDA has asked ReGen for a meeting to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness. However, on Monday, the devicemaker shot back. "ReGen Biologics Inc. is taking exception to the FDA's Center for Devices and Radiological Health's (CDRH) Thursday announcement of a plan to rescind the 510(k) clearance of the company's Menaflex knee implant," the company says in a sharply worded announcement.
"The politics surrounding changes suggested in the 510(k) program appear to underlie FDA actions, for example, a group of dissident FDA reviewers has sought legislative intervention because of their dissatisfaction with the current regulations and agency management," ReGen President and CEO Gerald Bisbee. "The agency's clearance of Menaflex has become a political football and the FDA is not playing by the rules."
The company adds that it is investigating alternatives for financing its European subsidiary, ReGen Biologics AG in order to continue marketing the Menaflex product in markets outside the U.S.
In a report released last September, the agency went as far as to admit that there were "multiple departures" from standard procedures during the 17-year review history of the CS device. The agency also admitted that it was unable to counter accusations that lobbying on behalf of ReGen had affected its decision. ReGen maintained that its product worked as it was intended.
- get the FDA's announcement
Panel questions data backing ReGen's Menaflex device
FDA: ReGen didn't provide adequate Menaflex data