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GHTF To Draft New IVD Guidelines Following Expansion Of Device Definition

This article was originally published in The Gray Sheet

Executive Summary

The Global Harmonization Task Force endorses the inclusion of in vitro diagnostics in further device-related harmonization efforts in a final document defining "medical device" released July 21

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Proposed Global Harmonization Guidelines Issued On In Vitro Diagnostics

The Global Harmonization Task Force May 14 proposed two guidelines to help standardize the regulation of in vitro diagnostics internationally

Proposed Global Harmonization Guidelines Issued On In Vitro Diagnostics

The Global Harmonization Task Force May 14 proposed two guidelines to help standardize the regulation of in vitro diagnostics internationally

GHTF docs

FDA is requesting 1comments by April 25 on Global Harmonization Task Force study group documents released in 2005, including the proposed guidances, "Principles of Medical Devices Classification," "Guidelines for Regulatory Auditing of Quality Management Systems - Part 2: Regulatory Auditing Strategy" (2"The Gray Sheet" Dec. 5, 2005, p. 18). The agency is also requesting feedback on the final documents, "Information Document Concerning the Definition of the Term 'Medical Device'" and "Essential Principles of Safety & Performance of Medical Devices" (3"The Gray Sheet" Aug. 1, 2005, p. 17)...

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