Devicemaker Targeted by 510(k) Critics

Orthopedic devicemaker ReGen Biologics is denying accusations that its device was wrongfully cleared by the FDA. “Certain lawmakers, members of the media and public interest groups are beating up on the Menaflex because they’re trying to change the 510(k) process,” ReGen’s CEO Gerald Bisbee said. The company is responding to reports that the FDA plans on re-examining its decision to approve ReGen’s collagen scaffold used to reinforce and repair the meniscus, which was cleared last year despite concerns from some FDA scientists and medical experts who questioned its safety.
Devices & Diagnostics Letter