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International Medical Device Regulatory Monitor
September 2012 | Vol. 20 No. 9
GHTF Outlines Reportable Events for Premarket Device Trials
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.
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