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ReGen Denies Improper Influence in FDA’s Menaflex Clearance

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.”

Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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