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Home » GHTF Outlines Reportable Events for Premarket Device Trials
GHTF Outlines Reportable Events for Premarket Device Trials
August 29, 2012
Medical devicemakers should report all adverse events in premarket clinical trials and any device deficiencies that might lead to a serious adverse event (SAE), according to the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.