[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Notices]
[Pages 67379-67380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27340]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1057]
Draft Guidance for Industry and Food and Drug Administration
Staff; Highly Multiplexed Microbiological/Medical Countermeasure In
Vitro Nucleic Acid Based Diagnostic Devices; 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availability of the draft guidance entitled ``Highly Multiplexed
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based
Diagnostic Devices.'' This draft guidance is to provide industry and
Agency staff with recommendations for studies to establish the
analytical and clinical performance of highly multiplexed
microbiological/medical countermeasures in vitro nucleic acid based
diagnostic devices (HMMDs) intended to simultaneously detect and
identify multiple pathogen nucleic acids extracted from a single
appropriate human specimen or culture. This draft guidance is not final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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 7, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Highly Multiplexed Microbiological/Medical
Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices'' 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Submit electronic comments on the draft guidance to http://www.regulations.gov.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: John Hobson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5555, Silver Spring, MD 20993-0002, 301-796-5892.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance is to provide industry and Agency staff with
recommendations for studies to establish the analytical and clinical
performance of HMMDs intended to simultaneously detect and identify
multiple pathogen nucleic acids extracted from a single appropriate
human specimen or culture. For the purposes of this draft guidance
document the multiplex level that is used to define HMMDs is the
capability to detect >=20 different organisms/targets, in a single
reaction, using a nucleic acid based technology and involves testing
multiple targets through a common process of specimen preparation,
amplification and/or detection, and result interpretation. HMMDs are
used to aid in the diagnosis of infection.
The scope of this draft guidance includes nucleic acid based
devices that employ technologies such as polymerase chain reaction,
reverse-transcriptase polymerase chain reaction, bead-based liquid
arrays, microarrays, re-sequencing approaches as well as the
measurement of individual targets determined by >=20 separate assays
that are reported out simultaneously through the use of a diagnostic
algorithm. This draft guidance is not intended to address devices that
utilize detection mechanisms other than nucleic acid based approaches.
The document does not apply to devices that are intended to screen
donors of blood and blood components, and donors of human cells,
tissues, and cellular and tissue-based products for communicable
diseases.
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 highly
multiplexed microbiological/medical countermeasure in vitro nucleic
acid based diagnostic devices. 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
``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro
Nucleic Acid Based Diagnostic Devices,'' you may either send an email
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 1803 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently approved collections of
information found in FDA regulations. 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 parts 801 and 809 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.
V. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.
[[Page 67380]]
Dated: October 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27340 Filed 11-8-12; 8:45 am]
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