ReGen Denies Improper Influence in FDA’s Menaflex Clearance

March 19, 2009
Orthopedics manufacturer ReGen Biologics has denied charges by Sen. Chuck Grassley (R-Iowa), the ranking member of the Senate Finance Committee, that it exerted improper influence over top FDA officials in the 510(k) clearance process for its Menaflex collagen scaffold. Grassley says in a statement that emails he obtained “make it look like the devicemaker was calling the shots and the FDA was going out of its way to accommodate the company.”
Devices & Diagnostics Letter