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OSTEOTECH REPORTS FDA TO REGULATE GRAFTON(TM) ALLOGENEIC BONE MATRIX AS A MEDICAL DEVICE

 SHREWSBURY, N.J., Sept. 27 /PRNewswire/ -- As has been previously reported by Osteotech (NASDAQ: OSTE), the United States Food and Drug Administration ("FDA") believes it has the statutory authority to regulate allograft processing and allograft bone tissues, but has not, in the past, exercised its product clearance authority. From its inception in 1986, Osteotech has voluntarily adapted its processing procedures to incorporate standards comparable to those of the pharmaceutical and medical device industry in anticipation of regulation. As the world's leading processor of allograft bone tissue, Osteotech has processed over 550,000 grafts during this time, providing its clients with high quality tissue for distribution to medical facilities worldwide.
 The FDA has initiated a project which is likely to lead to the regulation of these areas in the future. As a part of this process, the FDA has held or sponsored several public hearings and meetings with industry consultants and representatives, including Osteotech, to discuss issues related to safety, distribution and tracking of allograft bone tissue. In August 1993, the company prepared and provided the FDA with considerable scientific information on allograft processing and allograft bone tissue in the form of a comprehensive regulatory position paper.
 The company has received a letter from the FDA advising it that the FDA intends to regulate Grafton(TM) Allogeneic Bone Matrix as a medical device regardless of the existing exemption of demineralized bone from FDA clearance requirements. Grafton is a demineralized allograft bone matrix in a gel consistency. The FDA's letter requests that the company prepare and submit an application to conduct clinical research on Grafton if it wishes to continue providing Grafton to the medical community.
 Patrick McBrayer, president and chief executive officer of Osteotech, stated that "We believe that allograft bone tissue, including Grafton, if regulated by FDA, is most appropriately regulated as a medical device. As a result, the company has been preparing for the eventual regulation of Grafton as a medical device and plans to respond specifically to the FDA's request on a timely basis." McBrayer further stated that, "Osteopath will also continue to work proactively with the FDA in an effort to assist in appropriate regulation of all allograft bone tissue."
 Osteotech, Inc., headquartered in Shrewsbury, is a leading processor of human bone and bone connective tissue for transplantation and is also an innovator in the development of biologic, biomaterial and implant products for musculoskeletal surgery.
 -0- 9/27/93
 /CONTACT: Michael J. Jefferies of Osteotech, Inc., 908-542-2800/
 (OSTE)


CO: Osteotech, Inc. ST: New Jersey IN: MTC SU:

TM-OS -- NY085 -- 6070 09/27/93 16:29 EDT
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Publication:PR Newswire
Date:Sep 27, 1993
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