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Guidance for Industry and Food and Drug Administration Staff; Assayed and Unassayed Quality Control Material; Availability

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled “Assayed and Unassayed Quality Control Material.” The guidance describes FDA's current practices concerning assayed an unassayed quality control material, including information to include in a 510(k) for assayed quality control material, as well as labeling recommendations.


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 “Assayed and Unassayed Quality Control Material” 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. 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 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to​dockets/​ecomments. Identify comments with the docket number found in brackets in the heading of this document.

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Carol Benson, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0396.

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I. Background

This guidance document provides recommendations to manufacturers regarding preparation of premarket notifications and labeling for quality control (QC) material. These materials are intended to monitor reliability of a test system and help minimize reporting of incorrect test results. They are often the best source of ongoing feedback that a laboratory has to monitor whether results reported to physicians are sufficiently reliable. QC materials may be marketed together with a specific test system, or alternatively, for more general use.

Both assayed and unassayed QC materials are discussed in the guidance document. Both types of QC materials are subject to FDA's Quality System Regulation (part 820 (21 CFR part 820)) and labeling regulation (§ 809.10 (21 CFR 809.10)). However, most types of unassayed QC materials are exempt from premarket notification. (See “Classification and Identification of QC Material” of the guidance document for exceptions.) Although premarket notifications are number required for unassayed QC materials, some aspects of this guidance document concerning labeling, stability, and matrix effects are still relevant for these materials.

The draft version of this guidance was issued February 3, 1999. FDA received one set of comments on the draft guidance document during the comment period. The document reflects FDA's consideration of the comments and has also been updated to provide clarification as needed.

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 assayed and unassayed quality control material. 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 “Assayed and Unassayed Quality Control Material; Availability,” 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 (2231) 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.htm l. 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 U.S.C. 3501-3520). The collections of information in 21 CFR part 610 have been approved under OMB control number 0910-0206; the collections of information in 21 CFR part 807 have been approved under OMB control number 0910-0120; the collections of information in § 809.10 Start Printed Page 31590have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.

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. Comments received 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: May 31, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. E7-10996 Filed 6-6-07; 8:45 am]