[Federal Register: December 8, 2005 (Volume 70, Number 235)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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Draft Guidance for Industry and Food and Drug Administration;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.
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availability of the draft guidance entitled ``Nucleic Acid Based In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draft guidance document is being issued to provide guidance on the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DATES: Submit written or electronic comments on this draft guidance by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
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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.
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 This draft guidance replaces a previously issued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.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.
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
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