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GUIDANCE DOCUMENT

Biological Indicator (BI) Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff October 2007

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA regulates biological indicators (BI) intended to monitor sterilizers used in health care facilities as class II medical devices requiring premarket notification (510(k)). 21 CFR 880.2800(a). This guidance document provides information that will help manufacturers prepare 510(k)s for BIs used with conventional sterilization methods. FDA believes that providing this information will promote a consistent and efficient regulatory process.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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