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GHTF docs

This article was originally published in The Gray Sheet

Executive Summary

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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