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Germicide classification

This article was originally published in The Gray Sheet

Executive Summary

FDA's General Hospital and Personal Use Devices Advisory Panel is tentatively scheduled to meet in January 1995 to discuss classification of germicides. Germicides currently are regulated as accessories to the medical devices on which they are used; FDAers have suggested that germicides could be classified separately as Class II devices. Under a memorandum of understanding signed by FDA and the Environmental Protection Agency in June 1993, FDA has jurisdiction over sterilants used on critical and semicritical medical devices, whereas EPA has responsibility for general purpose disinfectants ("The Gray Sheet" June 21, 1993, I&W-5)

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