Regulatory Focus™ > News Articles > GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

Posted 02 February 2012 | By Alexander Gaffney, RAC 

The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called "Clinical Performance Studies for In Vitro Diagnostic Medical Devices." The document provides guidance for IVD medical devices, including the selection of clinical performance study design and the considerations to be made when undertaking those studies.

The document notes that "As IVD medical devices are used on specimens taken from the human body, the characteristics of clinical evidence are different from medical devices other than IVD medical devices."

Comments on the proposed document are due by 2 June 2012.        



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