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Global Harmonization Task Force Premarket Submission Pilot Outlined

This article was originally published in The Gray Sheet

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Executive Summary

FDA has identified 11 device categories eligible for a premarket submission pilot using an internationally harmonized format developed by the Global Harmonization Task Force.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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