Kessler to Chair FDA Medical Device Practices Harmonization Task Force
Dr. Larry Kessler, a senior FDA scientist and manager, will chair the Global Harmonization Task Force (GHTF) for the next eighteen months, announces the agency. Dr. Kessler, director of the Office of Science and Engineering Laboratories (OSEL) in FDA’s Center for Devices and Radiological Health (CDRH), assumed the chair on Dec, 22, 2006, replacing the Europeans as part of a rotation scheme among its five founding members (the U.S., Europe, Canada, Japan and Australia). GHTF is a voluntary group of representatives of national medical device regulatory authorities and trade associations of medical device manufacturers. Its main goals of GHTF are to advance the safety, effectiveness, performance and quality of medical devices; encourage technological innovation; foster international trade; and serve as a forum for exchange of information that can be of help to countries that are developing their own regulatory systems.
Since its was founded in 1992, GHTF has promoted the convergence of global regulatory practices by issuing almost 40 harmonized guidances, now widely followed by many countries. A study group at GHTF recently published guidance for adverse event reporting for medical devices (pdf), a topic that is currently part of the FDA’s agenda.
December 27, 2006 Related topics: Legal & legislative, People