[Federal Register: September 23, 2010 (Volume 75, Number 184)] [Notices] [Page 57963-57964] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr23se10-67]
———————————————————————–
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[Docket No. FDA-2010-D-0459]Draft Guidance for Industry and Food and Drug Administration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.
———————————————————————–
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availability of the draft guidance entitled “Establishing the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 This draft guidance document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 This draft guidance is not final nor is it in effect at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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 22, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled “Establishing the Performance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
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Submit electronic comments on the draft guidance to http://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
dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-S
