Guidance for Industry and Food and Drug Administration Staff; Biological Indicator Premarket Notification Submissions; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Biological Indicator (BI) Premarket Notification (510(k)) Submissions." The agency is issuing this guidance document to provide information that will help manufacturers prepare premarket notification submissions for these devices. The document provides guidance regarding performance characteristics for biological indicator devices, which are intended to monitor the effectiveness of sterilizers used in healthcare facilities.