GHTF Adds Draft Guidance Document on Clinical Performance Studies in IVDs

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

SG1 – Premarket Evaluation
SG2 – Post-Market Surveillance/Vigilance
SG3 – Quality Systems
SG4 – Auditing
SG5 – Clinical Safety/Performance
AHWG – Global Model
AHWG – Unique Device Identification
AHWG – Regulatory Change Management

In February 2012, GHTF issued a draft guidance document as listed below

SG5 – Clinical Safety/Performance
SG5(PD)/N8R3 Clinical Performance Studies for In Vitro Diagnostic Medical Devices
The comment period ends June 2, 2012

You can download these documents from at no charge. The proposed documents have a comment period and the GHTF solicits comments.