Document ID: FDA-2010-D-0636-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Performance Characteristics of in Vitro Diagnostic Devices for Detection of Antibodies to Borrelia Burgdorferi
Posted Date: 2011-01-05T05:00Z

[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 570-571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33293]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0636]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Establishing the Performance Characteristics of In Vitro 
Diagnostic Devices for the Detection of Antibodies to Borrelia 
Burgdorferi; 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availability of the draft guidance entitled ``Draft Guidance for 
Industry and Food and Drug Administration Staff; Establishing the 
Performance Characteristics of In Vitro Diagnostic Devices for the 
Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this 
draft guidance to provide industry and agency staff with 
recommendations for studies to establish the analytical and clinical 
performance of in vitro

[[Page 571]]

diagnostic devices (IVDs) intended for the detection of antibodies to 
Borrelia burgdorferi. These devices are used to aid in the diagnosis of 
Lyme disease. This draft guidance is not final nor is it in effect at 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 5, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and Food and 
Drug Administration Staff; Establishing the Performance Characteristics 
of In Vitro Diagnostic Devices for the Detection of Antibodies to 
Borrelia burgdorferi'' 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: Prasad Rao, Center for Devices and 
Radiological Health Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5508, Silver Spring, MD 20993-0002, 301-796-6203.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance recommends studies for establishing the 
performance characteristics of in vitro diagnostic devices for the 
detection of antibodies to B. burgdorferi in human serum, plasma, and 
blood. These devices are used to aid in the diagnosis of Lyme disease. 
This document does not apply to B. burgdorferi nucleic acid 
amplification assays. A manufacturer who intends to market an in vitro 
device for the detection of antibodies to B. burgdorferi must conform 
to the general controls of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) and, unless exempt, obtain premarket clearance or approval 
prior to marketing the device.

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 antibodies to B. burgdorferi. 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 
``Draft Guidance for Industry and Food and Drug Administration Staff; 
Establishing the Performance Characteristics of In Vitro Diagnostic 
Devices for the Detection of Antibodies to Borrelia burgdorferi,'' 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 1721 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. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (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 801 and 21 CFR 809.10 have been approved 
under OMB control number 0910-0485; the collections of information in 
21 CFR part 812 have been approved under OMB control number 0910-0078; 
the collections of information in 42 CFR 493.15 have been approved 
under OMB control number 0910-0598; the collections of information 21 
CFR 50.23 have been approved under OMB control number 0910-0586 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: December 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-33293 Filed 1-4-11; 8:45 am]
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