[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51182-51183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20291]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1082]
Highly Multiplexed Microbiological/Medical Countermeasure In
Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Highly Multiplexed
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based
Diagnostic Devices.'' This guidance is to provide industry and Agency
staff with recommendations for studies to establish the analytical and
clinical performance of highly multiplexed microbiological/medical
countermeasure 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.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro
Nucleic Acid Based Diagnostic Devices'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
Submit electronic comments on the 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. 5560, Silver Spring, MD 20993-0002, 301-796-5892.
SUPPLEMENTARY INFORMATION:
I. Background
This 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 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
[[Page 51183]]
to aid in the diagnosis of infection or screening for colonization.
The scope of this 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 via a common process of sample preparation, target
or signal amplification, allele discrimination, and collective
interpretation, and are reported out simultaneously. This 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.
The draft of this guidance was issued on November 9, 2012 (77 FR
67379). The comment period closed on February 7, 2013. Two sets of
comments were received and reviewed by FDA. The guidance was updated to
address comments where appropriate.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on HMMDs. 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 guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Highly Multiplexed
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based
Diagnostic Devices'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1803 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This 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 electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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.
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20291 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P