FDAnews Device Daily Bulletin

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. The document, authored by the GHTF’s Study Group 5, harmonizes with the International Organization for Standardization’s guideline on good clinical practice for device investigations.
International Medical Device Regulatory Monitor