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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




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.


Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.


Submit written requests for single copies of the guidance document entitled “Biological Indicator (BI) Premarket Notification (510(k)) Submissions” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151 or 1-800-638-2041. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Start Printed Page 56771Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either​dockets/​ecomments or Identify comments with the docket number found in brackets in the heading of this document.

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Sheila Murphey, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3747.

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I. Background

This guidance is for biological indicator devices intended for use in health care facilities to monitor the effectiveness of sterilizers. Biological sterilization process indicators are class II devices identified in 21 CFR 880.2800(a). In the Federal Register of May 21, 2001 (66 FR 27985), FDA invited interested persons to comment on the draft guidance entitled “Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers.”

FDA received five comments on the draft guidance. Many of the comments are addressed by the voluntary consensus standards that have been recognized by FDA since the draft was issued and that are now cited in the guidance. We addressed comments that suggested the statistics in the validation protocol were too restrictive by clarifying that these statistics are examples, not thresholds. We also revised the guidance for clarity and brevity in response to the comments received.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “biological indicator premarket notification submissions.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Biological Indicator (BI) Premarket Notification (510(k)) Submissions” you may either send an e-mail request to to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1320 to identify the guidance you are requesting.

CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at​cdrh. A search capability for all CDRH guidance documents is available at​cdrh/​guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB Control Number 0910-0120. The labeling provisions addressed in the guidance have been approved under OMB Control Number 0910-0485.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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Dated: September 26, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. E7-19573 Filed 10-3-07; 8:45 am]