The Global Harmonization Task Force
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*Larry Kessler, FDA 

Keywords: GHTF, safety, performance, clinical effectiveness

For 15 years, the GHTF has developed a series of guidance documents in order to harmonize regulatory processes for medical devices for its five founding members (Australia, Canada, EU, Japan, and US). In addition, these documents provide a structure for countries developing a regulatory system to follow. Concepts of safety, effectiveness, and device performance will be discussed. We will also talk about Premarket review issues and clinical evidence as well as how GHTF handles emergin technologies.