The FDA's plan to nullify the 510(k) clearance of ReGen Biologics' Menaflex knee implant was "totally unbelievable" and is being driven by a "political agenda," according to ReGen CEO Gerald Bisbee. Dr. Jeffrey Shuren, head of the FDA's device unit, countered the company's statement, saying the agency thoroughly reviewed the process for clearing the device and has the power to revoke the approval.

Related Summaries