[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Page 73106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29794]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0565]
Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of Clostridium difficile;
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availability of the draft guidance document entitled ``Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for the
Detection of Clostridium difficile.'' This draft guidance document
describes FDA's recommendations concerning 510(k) submissions for
various types of in vitro diagnostic devices (IVDs) intended to be used
for detecting Clostridium difficile (C. difficile). This draft guidance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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by February 28, 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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance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
Clostridium difficile'' 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Submit electronic comments on the draft guidance to http://www.regulations.gov.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, 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: Stephen Lovell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4435, Silver Spring, MD 20993-0002, 301-796-6968.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance includes recommendations concerning 510(k)
submissions for various types of (IVDs) intended to be used for
detecting C. difficile. The document is a revision of ``Review Criteria
for Assessment of Laboratory Tests Directed at Assisting in the
Diagnosis of C. difficile Associated Disease'' issued on May 31, 1990.
It is updated to include new issues and technologies identified since
the 1990 guidance. Such methods include detection of C. difficile
nucleic acids (e.g., C. difficile toxin B gene by nucleic acid
amplification methods such as the Real-Time Polymerase Chain Reaction
technique).
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 C. difficile. 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 Clostridium difficile,'' 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 1715 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
42 CFR section 493.15 have been approved under OMB control number 0910-
0598; the collections of information in 21 CFR section 50.23 have been
approved under OMB control number 0910-0586; and the collections of
information in 21 CFR section 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: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29794 Filed 11-26-10; 8:45 am]
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