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US industry warns on shift to GHTF (Global Harmonization Task Force) product review system

This article was originally published in Clinica

Executive Summary

AdvaMed, the Advanced Medical Technology Association, has recently raised concerns about the proposal for a uniform medical device classification system currently under development by the Global Harmonization Task Force (GHTF), the worldwide voluntary consortium of device regulators and trade associations. In a June 29 letter to the US FDA, the trade group warned that the four-tiered scheme proposed by the GHTF's study group one (SG1), on regulatory requirements and premarket review, could hamper product design and slow down product reviews.

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