Document ID: FDA-2011-D-0272-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Establishing Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis, etc.
Posted Date: 2011-05-11T04:00Z

[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27331-27332]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Establishing the 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 This draft guidance document provides industry 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 This draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 9, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 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 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 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]
BILLING CODE 4160-01-P