[Federal Register: April 10, 2006 (Volume 71, Number 68)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.
fda.gov/cdrh/guidance.html. Guidance documents are also available on
the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.
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
Dated: March 31, 2006.
Assistant Commissioner for Policy.
[FR Doc. E6-5203 Filed 4-7-06; 8:45 am]
BILLING CODE 4160-01-S