Osteotech regulatory update

The FDA informed OSTE that the agency intends to regulate Grafton Allogeneic Bone Matrix as a medical device regardless of the existing exemption of demineralized bone from FDA clearance requirements, OSTE said. The FDA in a letter asked OSTE to prepare and submit an application to conduct clinical research on Grafton if it wishes to continue providing the product to the medical community. The company said it has processed more than 550,000 bone grafts since its inception in 1986. ...