Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA reviews ReGen clearance at March panel: Agency's Orthopaedic and Rehabilitation Devices advisory panel will discuss the controversial 510(k) clearance of ReGen Biologics' Collagen Scaffold device, previously Menaflex, at a March 23 meeting. Last year, FDA launched an unprecedented re-assessment of its review of the knee repair device, 510(k)-cleared in December 2008, because of concerns that internal and political pressures may have hijacked the review process. The agency unearthed serious shortcomings in the integrity of the process, and FDA vowed to conduct a separate review of the Menaflex clearance to determine whether the data support 510(k) clearance, or whether the device should be up-classified to a Class III PMA device (1"The Gray Sheet" Sept. 28, 2009)