GHTF GUIDANCES FOCUS ON STANDARDS, REGULATORY AUDITS AND ADVERSE EVENT REPORTS
New guidance documents prepared by three study groups of the Global Harmonization Task Force (GHTF) should help smooth the way for more expedited device approvals and ease firms' ability to comply with foreign regulations.
The GHTF is a group of medical device regulatory and industry representatives from around the world. Its mission is to foster international regulatory convergence in an effort to decrease the costs of industry compliance and speed regulatory approval of new technologies and treatments.
The guidances were prepared by GHTF Study Groups 1, 2 and 4 as aids to governments in updating or developing regulatory requirements.
Study Group 1 was asked to identify differences between various regulatory systems, specifically differences in device design standards and essential device safety and performance criteria, known as "essential principles."
The study group's guidance also adds information on in vitro diagnostic devices that was not included in a 1999 guidance on the same topic.