Document ID: FDA-2010-D-0636-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff; Availability: Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi
Posted Date: 2013-03-28T04:00Z

[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Page 18988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07085]

[[Page 18988]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Establishing the Performance Characteristics of In Vitro 
Diagnostic Devices for the Detection of Antibodies to Borrelia 
burgdorferi; Guidance for Industry and Food and Drug Administration 
Staff; 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 guidance entitled ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection of 
Antibodies to Borrelia burgdorferi.'' FDA is issuing this guidance to 
provide industry and Agency staff with recommendations for studies to 
establish the analytical and clinical performance of in vitro 
diagnostic devices (IVDs) intended for the detection of antibodies to 
B. burgdorferi. These devices are used to aid in the diagnosis of Lyme 
disease.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``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 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, 301-796-6203.

SUPPLEMENTARY INFORMATION: 

I. Background

    This 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 and, unless exempt, obtain 
premarket clearance or approval prior to marketing the device.
    The draft guidance was announced in the Federal Register of January 
5, 2011 (76 FR 570), and the comment period closed on April 5, 2011. No 
comments were received during the comment period.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 the Detection of Antibodies to Borrelia burgdorferi,'' 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 1721 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 (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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07085 Filed 3-27-13; 8:45 am]
BILLING CODE 4160-01-P