

[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]               
[Page 8883-8884]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe08-64]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0095]

 
Draft Guidance for Industry and Food and Drug Administration 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.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Establishing the 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is issuing this draft guidance to inform industry and agency staff of 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:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by May 15, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled `` Establishing the Performance 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 (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    Submit written comments concerning this draft guidance to the 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.regulations.gov. 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 (HFZ-440) Food and Drug Administration 2098 
Gaither Rd., Rockville, MD 20850 240-276-0715.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft 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

[[Page 8884]]

and supplements other FDA documents that discuss the specific contents 
of premarket submissions.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent 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 draft guidance may do 
so by using the Internet. To receive ``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 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 1638 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/default.htm
.


IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. 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 
807 subpart E have been approved under OMB Control No. 0910-0120; the 
collections of information in 21 CFR parts 50 and 56 have been approved 
under OMB Control No. 0910-0130; the collections of information in 21 
CFR part 814 have been approved under OMB Control No. 0910-0231; the 
collections of information in 21 CFR part 812 have been approved under 
OMB Control No. 0910-0078; and the collections of information 
associated with CLIA waiver submissions and described in the draft 
guidance document for industry and FDA staff, ``Recommendations for 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver 
Applications'' have been approved under OMB Control No. 0910-0598.

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. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: February 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2826 Filed 2-14-08; 8:45 am]

BILLING CODE 4160-01-S
