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Medical Device Regulation Regulation

FDA Panel Endorses Class II Status for Surgical Mesh Instrumentation

This article was originally published in The Gray Sheet

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Executive Summary

The Gastroenterology and Urology Devices Panel supported FDA’s proposal to up-classify surgical mesh instrumentation from class I to class II with special controls.

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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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