Guideline

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Premarket Notifications [510(k)]for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers
Internet:	http://www.fda.gov/cdrh/ode/guidance/1320.pdf
Origin/Publisher:	FDA
Content:	This document provides guidance concerning the content and format of 510(k)submissions for biological sterilization process indicators (biological indicator)
Status:	Draft
Document Type:	Guidance