[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Notices]
[Page 41803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17777]
[[Page 41803]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0095]
Guidance for Industry and Food and Drug Administration Staff;
Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection and Differentiation of Influenza
Viruses; 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 entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection or
Detection and Differentiation of Influenza Viruses.'' FDA is issuing
this guidance to inform industry and Agency staff of its
recommendations for analytical and clinical performance studies to
support premarket submissions for in vitro diagnostic devices intended
for the detection or detection and differentiation of influenza
viruses.
DATES: Submit either electronic or written 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 ``Establishing the Performance Characteristics of In
Vitro Diagnostic Devices for the Detection or Detection and
Differentiation of Influenza Viruses'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Tamara Feldblyum, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5550, Silver Spring, MD 20993, 301-796-
6195.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document recommends studies that may be used to
establish the analytical and clinical performance of in vitro
diagnostic devices (IVDs) for the detection or detection and
differentiation of influenza viruses. The document addresses devices
that detect either influenza viral antigens or influenza viral genome
(protein or nucleic acid), including those for novel influenza viruses
in either human specimens or culture isolate. The guidance does not
address devices that detect serological response from the host to the
viral antigen, nor does it address establishing performance of non-
influenza components of multi-analyte or multiplex devices. This
guidance document identifies the classification regulations and product
codes for existing legally marketed influenza tests and supplements
other FDA documents that discuss the specific contents of premarket
submissions. The draft of the guidance was issued for comment for 90
days on February 15, 2008. A total of four sets of comments were
received. In response to comments, FDA made clarifying edits in several
sections, and also added a section on determining the assay cut-off and
equivocal zone. In addition, to address growing complexity of the
devices, new sections were added regarding labeling, instrumentation,
hardware and software, use of fresh and frozen specimens, nucleic acids
extraction methods, and recommendations to help monitor postmarket
device performance.
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 ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection or
Detection and Differentiation of Influenza Viruses.'' 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. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
the document ``Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection or Detection and Differentiation
of Influenza Viruses,'' 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 301-847-8149 to receive a hard copy. Please use
the document number 1638 to identify the guidance you are requesting.
IV. Paperwork Reduction Act
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 56.115 have been approved under
OMB control number 0910-0130; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR 809.10 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073; and the
collections of information in 42 CFR part 493 have been approved under
OMB control number 0910-0598.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
Dated: July 11, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-17777 Filed 7-14-11; 8:45 am]
BILLING CODE 4160-01-P