[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]
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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Draft Guidance for Industry and Food and Drug Administration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.
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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availability of the draft guidance entitled ``Establishing the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is issuing this draft guidance to inform industry and agency staff of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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled `` Establishing the Performance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Submit written comments concerning this draft guidance to the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]
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