Document ID: FDA-2010-D-0634-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance, Establishing Performance Characteristics of Nucleic Acid-Based in Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistnat Staphylococcus and Staphylococcus Aureus
Posted Date: 2011-01-05T05:00Z

[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 569-570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0634]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Establishing the Performance Characteristics of Nucleic Acid-
Based In Vitro Diagnostic Devices for the Detection and Differentiation 
of Methicillin-Resistant Staphylococcus aureus and Staphylococcus 
aureus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 570]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Establishing the 
Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic 
Devices for the Detection and Differentiation of Methicillin-Resistant 
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The 
draft guidance document provides industry and Agency staff with updated 
recommendations for studies to establish the analytical and clinical 
performance of nucleic acid-based in vitro diagnostic devices (IVDs) 
intended for the detection and differentiation of methicillin-resistant 
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 5, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 
Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for 
the Detection and Differentiation of Methicillin-Resistant 
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)'' 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: Li Li, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5558, Silver Spring, MD 20993-0002, 301-796-6200.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing the draft guidance to provide industry and Agency 
staff with recommendations for studies to establish the analytical and 
clinical performance of nucleic acid-based IVDs intended for the 
detection and differentiation of MRSA and SA. These devices are used to 
aid in the prevention and control of MRSA/SA infections in healthcare 
settings. This document is limited to studies intended to establish the 
performance characteristics of devices that detect the MRSA/SA genome 
(nucleic acid). It does not address detection of MRSA/SA antigens or 
serological response from the host to the MRSA/SA antigens, nor does it 
address establishing performance of non-MRSA/SA components of multi-
analyte 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 nucleic acid-based IVDs for the 
detection and differentiation of MRSA and SA. 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 Nucleic Acid-Based In 
vitro Diagnostic Devices for the Detection and Differentiation of 
Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus 
aureus (SA),'' 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 1722 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The 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 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. 2010-33292 Filed 1-4-11; 8:45 am]
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