[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