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Quality Digest

FDA Compliance

New Chairman for Global Harmonization Task Force

Published: Tuesday, January 23, 2007 - 23:00

A Food and Drug Administration senior scientist will be the next chairman for the agency’s Global Harmonization Task Force, which was established as an international effort to improve the quality of medical devices and regulatory systems.

Dr. Larry Kessler is director of the office of science and engineering laboratories, which is a division of the FDA’s center for devices and radiological health. He assumed the chairmanship in December and will hold the position for 18 months.

Since it was founded in 1992, the GHTF has issued almost 40 harmonized guidance documents designed to help developing countries implement effective regulatory systems for medical devices and pharmaceutical manufacturing.

Kessler was chairman of a GHTF study group from 1996 to 2000 that reviewed post-marketing surveillance of medical devices in the task force’s founding countries, which include the United States, Japan, Canada and Australia. The study group also produced major documents that helped establish a harmonized, international system of reporting adverse events associated with medical devices.

Prior to joining the FDA in 1995, Kessler worked with the National Cancer Institute, where he served as the chief of its applied research branch. His first position at the FDA was as director of its office of surveillance and biometrics, a part of the FDA’s center for devices and radiological health. There, he guided the agency’s medical device reporting regulation and began testing a sentinel system for the reporting of adverse events by user facilities.

“I have full confidence in Dr. Kessler to fulfill his responsibilities as chair of this global initiative to help harmonize medical device regulatory practices and help drive further technological progress in the medical device industry,” says FDA commissioner, Dr. Andrew con Eschenbach.

For more information, visit www.fda.gov/bbs/topics/NEWS/2006/NEW01540.html.


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