[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27331-27332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11532]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0272]
Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria
Gonorrhoeae: Screening and Diagnostic Testing; 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availability of the draft guidance entitled ``Establishing the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
Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and
Diagnostic Testing.'' This draft guidance document provides industry
and Agency staff with recommendations for studies to establish the
analytical and clinical performance of in vitro diagnostic devices
(IVDs) intended for C. trachomatis and/or N. gonorrhoeae screening and
diagnostic testing using nucleic acid based assays. This draft guidance
is not final nor is it in effect at this time.
[[Page 27332]]
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 9, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for Chlamydia
Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic
Testing'' 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Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kathleen Whitaker, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5500, Silver Spring, MD 20993-0002, 301-
796-6208.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this draft guidance to provide industry and Agency
staff with recommendations for studies to establish the analytical and
clinical performance of IVDs intended for C. trachomatis and/or N.
gonorrhoeae screening and diagnostic testing using nucleic acid based
assays. These devices are used to aid in the diagnosis of urogenital C.
trachomatis and N. gonorrhoeae infection. They include devices that
detect one specific organism, as well as devices that may detect both
organisms with or without further differentiation.
This draft guidance provides detailed information on the types of
studies FDA recommends to support class I and class II premarket
submissions for these devices. The draft guidance includes a list of C.
trachomatis and N. gonorrhoeae strains recommended for analytical
sensitivity studies and a list of micro-organisms recommended for
analytical specificity studies. This document also addresses
recommendations for fulfilling labeling requirements applicable to all
in vitro diagnostic devices intended to screen for, or aid in the
diagnosis of, C. trachomatis and/or N. gonorrhoeae directly from human
specimens.
This document is limited to studies intended to establish the
performance characteristics of devices that detect chlamydial and/or
gonococcal nucleic acid. It does not address detection of serological
response from the host to bacterial antigens, nor does it address
establishing performance of non-chlamydial or non-gonococcal components
of multianalyte or multiplex devices.
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 C.
trachomatis and/or N. gonorrhoeae screening and diagnostic testing. 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. 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. To receive
``Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae:
Screening and Diagnostic Testing,'' you may either send an e-mail
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 1733 to identify the guidance you are
requesting.
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 number 0910-0120;
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 parts 56.115 have been approved under OMB control number 0910-
0130; and the collections of information in 21 CFR part 801 and 21 CFR
809.10 have been approved under OMB control number 0910-0485.
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: May 6, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-11532 Filed 5-10-11; 8:45 am]
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