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FDA GERMICIDE 510(K) GUIDANCE WILL ADDRESS AGENCY'S SOLE AUTHORITY OVER STERILANTS/HIGH-LEVEL DISINFECTANTS; DOCUMENT WILL CLEAR WAY FOR CLASS II STATUS

This article was originally published in The Gray Sheet

Executive Summary

FDA is extending the comment period for its draft 510(k) guidance on liquid chemical germicides in order to gain input on how the document should address FDA's new sole jurisdiction over sterilants and high-level disinfectants. An upcoming Federal Register notice will announce an extension of 90 days beyond the original March 6 closing date for the comment period.
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