Home > Newsletters > Devices & Diagnostics Letter > GHTF Guidance Asks Devicemakers to Report All Trial Adverse Events
Devices & Diagnostics Letter
Sept. 3, 2012 | Vol. 39 No. 35
GHTF Guidance Asks Devicemakers to Report All Trial Adverse Events
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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