Document ID: FDA-2010-D-0565-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Availability, etc.: Establishing Performance Characteristics of In Vitro Diagnostic Devices for Detection of Clostridium difficile
Posted Date: 2010-11-29T05:00Z

[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]               
[Page 73106]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no10-103]                         

-----------------------------------------------------------------------

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Draft Guidance for Industry and Food and Drug Administration 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.

-----------------------------------------------------------------------

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availability of the draft guidance document entitled ``Establishing the 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 This draft guidance document 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 This draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 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 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 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]
BILLING CODE 4160-01-P