The Global Harmonization Task Force (GHTF) recently posted two new documents.
The GHTF Steering Committee posted a final document entitled “Definition and Glossary of Terms Used in GHTF Documents”. This document has a list of the definitions used in GHTF final documents. By consolidating the definitions into a single list, GHTF produced a useful Glossary of Terms.
GHTF Study Group 2 (Post-Market Surveillance/Vigilance) and Study Group 5 (Clinical Safety/Performance) published a proposed document for comment. The document is entitled “Reportable Events During Pre-Market Clinical Investigations” and is open for comment until December 10, 2011. The document is intended as a global model to provide guidance on the types of adverse events to report to National competent Authorities when conducting clinical investigations. The proposed document also utilizes ISO 14155:2011 Clinical Investigations of medical devices for human subjects – Good clinical practice.
Note that as of July 3, 2011
- ISO 14155 is not an FDA recognized consensus standard.
- ISO 14155:2011 is not harmonized to the MDD (but the earlier version is.)