A Medical Device Daily

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 (CDRH), 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.

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.

His first position at FDA was as director of CDRH’s Office of Surveillance and Biometrics, a role in which he guided the implementation of the agency’s Medical Device Reporting regulation, developed a program for reducing the burden of repetitive reporting and began testing a sentinel system for the reporting of adverse events by user facilities. He also helped develop a new program to encourage the application of a variety of new Bayesian statistical methods for the review process for medical devices, which the FDA says has sped up the development and approval of some innovative technologies.

From September 2001 through August 2002, Kessler was a visiting scientist at the Fred Hutchinson Cancer Research Center (Seattle, Washington), where he conducted research on colorectal and lung cancer, examined trends in prostate cancer and worked on the National Emphysema Treatment Trial. He has directed, since September 2002, OSEL, which plays a role in identifying key scientific questions and solutions concerning the safety and effectiveness of medical devices.

No Comments