[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Pages 73010-73011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0434]


Draft Guidance for Industry and Food and Drug Administration; 
Nucleic Acid Based In Vitro Diagnostic Devices for Detection of 
Microbial Pathogens; 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availability of the draft guidance entitled ``Nucleic Acid Based In 
Vitro Diagnostic Devices for Detection of Microbial Pathogens.'' This 
draft guidance document is being issued to provide guidance on the 
types of information and data to consider when preparing or reviewing 
premarket submissions for nucleic acid based in vitro diagnostic 
devices for the detection of microbial pathogens.

DATES:  Submit written or electronic comments on this draft guidance by 
March 8, 2006.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Nucleic Acid Based In 
Vitro Diagnostic Devices for Detection of Microbial Pathogens'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or FAX your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Roxanne Shively, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496 ext. 113.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft document is intended to provide a basic framework for 
the types of information and data that we believe should be addressed 
in the premarket review of a nucleic acid based device for detecting 
microbial pathogens. This draft guidance replaces a previously issued 
document entitled ``Review Criteria for Nucleic Acid Amplification-
based in vitro Diagnostic Devices for Direct Detection of Infectious 
Microorganisms'' (June 1993). The current draft reflects changes in the 
technologies available for nucleic acid detection, and expanded use in 
clinical laboratories. The recommendations within this draft guidance 
apply broadly to premarket review of these in vitro diagnostic devices 
for detecting microbial pathogens. Enzymatic amplification may or may 
not be part of the applied technology.

[[Page 73011]]

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 ``Nucleic 
Acid Based In Vitro Diagnostic Devices for Detection of Microbial 
Pathogens.'' 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

    To receive ``Nucleic Acid Based In Vitro Diagnostic Devices for 
Detection of Microbial Pathogens'' by FAX, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system. At the second voice prompt, 
press 1 to order a document. Enter the document number (1560) followed 
by the pound sign (). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). 
The collections of information addressed in the draft guidance document 
have been approved by OMB in accordance with the PRA under the 
regulations governing premarket notification submissions (21 CFR part 
807, subpart E, OMB control number 0910-0120 and premarket approval 
applications 21 CFR part 814, OMB control number 0910-0231). The 
labeling provisions addressed in the guidance have been approved by OMB 
under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit one copy of electronic comments or two paper copies of 
any mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Comments received may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 28, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-23746 Filed 12-7-05; 8:45 am]
BILLING CODE 4160-01-S