[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Pages 57963-57964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0459]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Establishing the Performance Characteristics of In Vitro 
Diagnostic Devices for the Detection of Helicobacter pylori; 
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availability of the draft guidance entitled ``Establishing the 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 of Helicobacter pylori.'' This draft guidance document 
provides industry and agency staff with updated recommendations 
concerning 510(k) submissions for various types of in vitro diagnostic 
devices (IVDs) intended to be used for detecting Helicobacter pylori 
(H. pylori). This draft guidance is not final nor is it in effect at 
this time.

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 of 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 22, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 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 of 
Helicobacter pylori'' to the Division of

[[Page 57964]]

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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Freddie M. Poole, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5520, Silver Spring, MD 20993-0002, 301-
796-5457.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document provides recommendations on developing 
studies for establishing the performance characteristics of in vitro 
diagnostic devices for the direct or indirect detection of H. pylori 
bacteria in human blood, serum, urine, stool, or breath specimens. FDA 
believes these recommended studies will be relevant for premarket 
notification (510(k)) submissions for these device types. Detection 
methods listed in this guidance include blood and urine antibody tests, 
stool antigen test, carbon-13 (\13\C) urea breath and blood tests, and 
the urease test. This draft guidance has been updated since the 1992 
guidance document entitled ``Review Criteria for Assessment of 
Laboratory Tests for the Detection of Antibodies to Helicobacter 
pylori,'' to suggest information that submitters provide that is more 
appropriate given changes in understanding of the science of detection 
of H. pylori and to include technologies outside the scope of the old 
guidance, such as H. pylori urea breath tests and H. pylori antigen 
detection tests.

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 of H. pylori. 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 of 
Helicobacter pylori'' you may either send an email 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 1712 to identify the draft guidance you are 
requesting. 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.

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 
812 have been approved under OMB control number 0910-0078; 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 42 CFR 493.17 have been approved under OMB control 
number 0910-0607; and the collections of information in 21 CFR 56.115 
have been approved under OMB control number 0910-0130.

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: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23644 Filed 9-22-10; 8:45 am]
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