[Federal Register: January 5, 2011 (Volume 76, Number 3)] [Notices] [Page 569-570] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05ja11-58]
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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[Docket No. FDA-2010-D-0634]Draft Guidance for Industry and Food and Drug Administration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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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availability of the draft guidance entitled “Establishing the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draft guidance document provides industry and Agency staff with updated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 This draft
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 5, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled “Establishing the Performance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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