FDA clears first-of-its-kind suture made using DNA technology
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Md. -- The
U.S. Food and Drug Administration (FDA) this week announced it has
cleared for marketing in the U.S. 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, Center for Devices and
Radiological Health, FDA. "This approach could have broader
applications for medical devices that use this novel manufacturing
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.
FDA reviewed safety and effectiveness information for the device
under the de novo petition process. De novo
petitions were added under the Food and Drug Administration
Modernization Act of 1997 to find a way for novel but less risky
products to get to market. As a result of its review, FDA determined
that products of this type will be regulated as class II
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The device is contraindicated in patients allergic to the cells
or the growth media used to produce the absorbable polymeric
Doctors use sutures in patients to hold soft tissue together
while the tissue heals from a deep cut or surgical incision.
Absorbable sutures are made of materials that break down in the body
after a short period of time.
TephaFLEX Absorbable Suture is manufactured by Tepha, Inc., of
FDA's regulation of all medical devices is risk-based, with
devices classified into low-risk (class I), moderate-risk (class II)
or high-risk (class III) categories. The FDA regulatory program for
medical devices is comprehensive and includes requirements for
registration and listing of products, premarket evaluation,
high-quality production using good manufacturing practices, and
post-market reporting of adverse events.
U.S. Food and Drug Administration news release)