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FDA Gets Knocked Out in Endotec, Inc. Ruling
Date:8/18/2008

o the July 21, 2008 e-newsletter, Health Imaging News, the FDA has lost enormous expertise in medical device regulation. " ... almost all of the leadership at the office of regulatory is leaving, including Associate Commissioner of Regulatory Affairs Margaret Glavin, who is retiring, and Assistant Commissioner for Compliance Policy David Horowitz, who was recently promoted to assistant commissioner for policy for the FDA. Deputy Director Deborah Ralston has left the agency as well."

The Endotec case revolved around the specifics of the FDA's approval procedures for medical devices. Most "class III" devices, which support human life or present a risk of injury, require FDA approval before they can be sold. The only exception is for "custom devices," which are not generally available and are intended for a specific patient, or made to the specifications of a specific surgeon for use in his or her practice.

About Endotec

Endotec Inc., founded in 1988, is a medical device company that specializes in the manufacture and distribution of biocompatible orthopedic implant products. The company's products include hip replacement and knee replacement, as well as the shoulder and ankle extremities.

Contact:

Norman Booth

Coyne Public Relations

(973) 939-8144

nbooth@coynepr.com


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SOURCE Endotec Inc.
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