[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31589-31590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-1232] (formerly 98D-1232)


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: 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 http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION:

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 (Sec.  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 
[email protected] 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 http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/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 Sec.  809.10

[[Page 31590]]

have 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.

    Dated: May 31, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-10996 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S