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.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.