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General Hospital Panel Clarification

This article was originally published in The Gray Sheet

Executive Summary

In discussion by FDA's General Hospital and Personal Use Devices panel Sept. 14 on classification of all previously unclassified washers and washer-disinfectors intended for processing reusable devices ("The Gray Sheet" Sept. 21, p. 4), industry representative Salvadore Palomares (ICU Medical) argued to have washers classified as Class I and washer disinfectors classified as Class II. He cast a dissenting vote to the panel's Class II recommendation for both devices



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