Spine implant maker reaches $1M settlement with FDA.
According to Reuters, Globus Medical Inc and its chief executive officer have reached a $1 million settlement with the US Food and Drug Administration for marketing their NuBone Osteoinductive Bone Graft device without approval from the agency.
During a September 2010 inspection, FDA investigators learned the company had marketed its NuBone Osteoinductive Bone Graft product without proper regulatory approval.
Globus had sought clearance for the product in January 2009, but FDA declined to approve it after determining that it was not substantially equivalent to legally marketed products. The company continued to distribute the product anyway.