[Federal Register Volume 71, Number 68 (Monday, April 10, 2006)]
[Notices]
[Pages 18107-18108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5203]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0121]


Guidance for Industry and Food and Drug Administration Staff; In 
Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and 
Regulatory Path; 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 ``In Vitro Diagnostic Devices to 
Detect Influenza A Viruses: Labeling and Regulatory Path.'' FDA is 
issuing this guidance to inform industry and agency staff of steps that 
are needed to ensure the safe and effective use of in vitro diagnostic 
(IVD) devices intended for use in the detection of influenza A (or A/B) 
virus directly from human specimens. FDA is taking this action because 
of recent significant public health concerns associated with emergence 
of an avian influenza A virus strain as a human pathogen in Southeast 
Asia. This guidance document describes recommendations for fulfilling 
labeling requirements applicable to all IVDs intended to generally 
detect influenza A (or A/B) virus directly from human specimens, and 
outlines the premarket regulatory path for new or modified devices 
intended to generally detect influenza A virus, or to detect and 
differentiate, specific novel influenza A viruses infecting humans. 
This guidance document is immediately in effect, but it remains subject 
to comment in accordance with the agency's good guidance practices.

DATES: Submit written or electronic comments on this guidance at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``In Vitro Diagnostic Devices to Detect Influenza A 
Viruses: Labeling and Regulatory Path'' 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 301-443-8818. 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://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

    The spread of the influenza A H5N1 virus within bird species, along 
with sporadic transmission to humans, has heightened awareness of the 
potential for a novel influenza A virus to cause a pandemic in humans. 
Novel influenza A viruses are new or re-emergent human strains of 
influenza A that cause cases or clusters of human disease, as opposed 
to those human strains commonly circulating that cause seasonal 
influenza and to which human populations have residual or limited 
immunity (either by vaccination or previous infection). All of the 
influenza A (or A/B) devices cleared by FDA under 21 CFR 866.3330 
before February 3, 2006, are designed to generally detect influenza A 
viruses in human respiratory specimens (e.g., washes, aspirates, and 
swabs). None of these devices is designed or intended to detect a 
specific influenza A virus, or to detect and differentiate one specific 
influenza A virus from another (e.g., H5N1 from H3N2). For devices 
cleared on the basis of performance characteristics established when 
only influenza A/H3 and A/H1 viruses were circulating, there is no 
evidence that the devices would reliably detect novel influenza A 
viruses from human respiratory samples. Also, these testing devices are 
not intended to detect and differentiate a specific human-infecting 
novel influenza A virus. FDA is making this guidance document 
immediately available because prior public participation is not 
feasible given the national and global public health threat of pandemic 
influenza. At this time public health officials are expediting plans to 
prepare for and respond to this threat. Immediate implementation of 
this guidance is part of this preparedness effort as it clarifies the 
role of in vitro diagnostic devices for the detection and/or 
differentiation of novel influenza A viruses.

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 labeling and regulatory path for in vitro 
diagnostic devices to detect influenza A 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

    To receive ``In Vitro Diagnostic Devices to Detect Influenza A 
Viruses: Labeling and Regulatory Path'' by fax machine, call the CDRH 
Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. Press 1 to enter the system. At the second voice 
prompt, press 1 to order a document. Enter the document number 1549 
followed by the pound sign (). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. 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.

[[Page 18108]]

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.

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 809 have been approved under 
OMB Control No. 0910-0485; the collections of information in 21 CFR 
part 807 have been approved under OMB Control No. 0910-0120; the 
collections of information in 21 CFR part 812 have been approved under 
OMB Control No. 0910-0078.

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 
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: March 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5203 Filed 4-7-06; 8:45 am]
BILLING CODE 4160-01-S