Advisory Panel to Reconsider Clearance for Menaflex

The FDA has asked the Orthopedic and Rehabilitation Devices Panel to reconsider the 510(k) clearance of ReGen Biologics’ Menaflex collagen scaffold March 23. The panel, which recommended clearance for the device in 2008, will weigh in on whether the device should retain its 510(k) or should have to go through a PMA process. ReGen CEO Gerald Bisbee declined to say whether the company would file a PMA application should the panel and the FDA agree one is needed.
Devices & Diagnostics Letter