[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34999-35000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14789]
-----------------------------------------------------------------------
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Draft Guidance for Industry and Food and Drug Administration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.
-----------------------------------------------------------------------
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availability of the draft guidance entitled ``Establishing the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 This draft guidance document provides industry and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 This draft guidance is not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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 13, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance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 [email protected] 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]
BILLING CODE 4160-01-P