A Diagnostics & Imaging Week

The FDA reported that Dr. Larry Kessler, a senior FDA scientist and manager, will chair the Global Harmonization Task Force (GHTF) for the next 18 months.

Kessler, director of the Office of Science and Engineering Laboratories (OSEL) in the FDA’s Center for Devices and Radiological Health, assumed the chair of the forum of medical device regulators and trade associations on Dec, 22.

“We’re very proud of the opportunity for HHS/FDA to chair this initiative for the next 18 months,” said Andrew von Eschenbach, MD, commissioner of the FDA, saying that the global initiative to help harmonize medical device regulatory practices will help drive “further technological progress in the medical device industry.”

GHTF is a voluntary group of representatives of national medical device regulatory authorities and trade associations of medical device manufacturers. The founding members came from the U.S., Europe, Canada, Japan and Australia. It describes its goals as: advancing the safety, effectiveness, performance and quality of medical devices; encouraging technological innovation; fostering international trade; and serving as a forum for exchange of information that can be of help to countries that are developing their own regulatory systems. Since its founding in 1992, GHTF has promoted the convergence of global regulatory practices by issuing almost 40 harmonized guidances, now followed by many countries.

Kessler has contributed to these accomplishments as the chair in 1996-2001 of a GHTF Study Group that reviewed the programs for the post-marketing surveillance of medical devices in the founding countries, and which established a mechanism for regulators to exchange significant post-market device information about adverse events, called the National Competent Authority Reporting program.

This Study Group also set a standard for a unified, world-wide system of reporting adverse events associated with medical devices by producing major documents on what defines an adverse event, and what, when and how to report it.

Kessler joined FDA in 1995 after a decade with the National Cancer Institute, part of the National Institutes of Health, where he served for nine years as the chief of the Applied Research Branch.

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