FDA Clears First-of-Its-Kind Suture Made Using DNA Technology
MedSun: Newsletter #12, February 2007

FDA announced on February 12, 2007, that it has cleared for marketing in the United States the TephaFLEX Absorbable Suture, the first absorbable polymer suture made from material isolated from bacteria modified by recombinant DNA technology. Recombinant DNA technology uses living organisms to create chemicals that may be more difficult to produce under standard industrial methods.

"The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology," said Daniel Schultz, M.D., Director of the Center for Devices and Radiological Health of FDA.

"This approach could have broader applications for medical devices that use this novel manufacturing technology." FDA based its decision on the company's laboratory and animal testing that examined chemical composition, biological safety, and mechanical performance of the polymeric suture. The company provided data to show that the suture could be manufactured in a consistent and safe manner.

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