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www.fdanews.com/articles/138140-ghtf-develops-ae-reporting-system-for-premarket-trials

GHTF Develops AE Reporting System for Premarket Trials

July 6, 2011
A proposed Global Harmonization Task Force (GHTF) document aims to create a uniform system for premarket adverse event (AE) reporting as part of the approval process. The requirements for adverse event reporting should be more stringent than postmarket vigilance requirements, as the devices may not have been previously used in humans.
International Medical Device Regulatory Monitor