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Hemostatic Agent Downclassification Should Await Guidance – Panel

This article was originally published in The Gray Sheet

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Executive Summary

FDA plans to develop a draft guidance document for absorbable hemostatic agent 510(k) submissions and submit it for panel review before reconsidering downclassification of the devices
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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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