FDA is seeking comment on documents from two study groups of the Global Harmonization Task Force. They are available for public comment until October 9, according to a Federal Register notice. The agency is particularly interested in whether stakeholders think any parts of the GHTF documents are incompatible with FDA regulations.
Study Group 1 has published a final document called “Role of Standards.” It provides information on the use of standards by a manufacturer when designing a medical device and, subsequently, when demonstrating that the device conforms to relevant essential safety and performance criteria.
Study Group 5 has published a draft document called “Clinical Investigations.” It discusses general principles of clinical investigations of medical devices and general principles when considering the need for a clinical investigation of a medical device.
The GHTF issues guidance to help developed countries make their medical device regulatory systems more compatible with each other, and to help less-developed countries implement their own regulatory systems.
Electronic comments can be submitted here. Be sure to enter Docket No. FDA-2008-D-0372.
July 15th, 2008 at 4:05 am
i think this will help people globally…
clinical research is a very sensitive field…n its requires lots of professionals…
hospitals all over the world have crying need for professionals to manage them…
this initiative by GHTF will be a huge success..
ICRI in India is also one of the premier institutes of the country and aims at promoting clinical research.