Document ID: FDA-2014-N-1082-0001
Agency: fda
Document Type: Notice
Title: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro
Nucleic Acid Based Diagnostic Devices; Guidance for Industry and
Food and Drug Administration Staff; Availability
Posted Date: 2014-08-27T04:00Z

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51182-51183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20291]

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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.

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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 CDRH-Guidance@fda.hhs.gov 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