Document ID: FDA-2011-D-0378-0001
Agency: fda
Document Type: Notice
Title: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-Cased Devices - Notice of Availability
Posted Date: 2011-06-15T04:00Z

[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34999-35000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14789]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0378]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Establishing the Performance Characteristics of In Vitro 
Diagnostic Devices for the Detection of Methicillin-Resistant 
Staphylococcus Aureus for Culture-Based Devices; 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availability of the draft guidance entitled ``Establishing the 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 the 
Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-
Based Devices.'' This draft guidance document provides industry and 
Agency staff with recommendations for studies for establishing the 
performance characteristics of in vitro diagnostic devices for the 
detection of methicillin-resistant S. aureus (MRSA), including those 
for the detection or detection and differentiation of MRSA versus S. 
aureus (SA) in either human specimens or bacterial growth detected by 
continuous monitoring blood culture systems. This draft guidance is not 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 on 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 13, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection of 
Methicillin-Resistant Staphylococcus Aureus (MRSA) for Culture-Based 
Devices'' 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: Alexandra Wong, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5502, Silver Spring, MD 20993-0002, 301-796-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is issuing this draft guidance to provide industry and Agency 
staff with recommendations for studies for establishing the performance

[[Page 35000]]

characteristics of in vitro diagnostic devices for the detection of 
MRSA, including those for the detection or detection and 
differentiation of MRSA versus SA in either human specimens or 
bacterial growth detected by continuous monitoring blood culture 
systems. These devices are used to aid in the prevention and control of 
MRSA/SA infections in health care settings. This document is limited to 
studies intended to establish the performance characteristics of 
devices that detect MRSA by growth in culture media or those devices 
that test for the protein, penicillin-binding protein 2a (PBP2a or 
PBP2'), expressed by the mecA gene. This includes culture-based devices 
that use selective or chromogenic media. It does not address the 
detection of serological response from the host to the MRSA antigens or 
establish the performance of non-MRSA components of multianalyte or 
multiplex nucleic acid based 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 the 
detection of MRSA for culture-based devices. 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 the Detection of Methicillin-Resistant Staphylococcus 
Aureus (MRSA) for Culture-Based Devices,'' 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 1729 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 part 801 and 21 CFR 809.10 have been approved under OMB control 
number 0910-0485; and the collections of information in 42 CFR 493.15 
have been approved under OMB control number 0910-0598.

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: June 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-14789 Filed 6-14-11; 8:45 am]
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