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WOUND DRESSING CLINICAL ENDPOINTS SHOULD REFLECT "CONDITION FOR USE," FDA PANEL MEMBER SUGGESTS; AGENCY PLANS REPROPOSAL OF CLASSIFICATIONS FOR PRODUCTS

This article was originally published in The Gray Sheet

Executive Summary

FDA's guidance document on investigational device exemption studies of "interactive" wound and burn dressings should outline clinical endpoints based on "condition for use" of a device, Steven Boyce, MD, University of Cincinnati Medical Center, suggested at the Sept. 21 meeting of FDA's General and Plastic Surgery Devices Panel in Gaithersburg, Maryland.
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