[Federal Register: June 7, 2007 (Volume 72, Number 109)]
[Notices]
[Page 31589-31590]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn07-61]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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