Document ID: FDA-2012-D-1057-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Staff; Availability: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices
Posted Date: 2012-11-09T05:00Z

[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Notices]
[Pages 67379-67380]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27340]

-----------------------------------------------------------------------

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Draft Guidance for Industry and Food and Drug Administration 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.

-----------------------------------------------------------------------

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availability of the draft guidance entitled ``Highly Multiplexed 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 This draft guidance is to provide industry and 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 This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 7, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Highly Multiplexed Microbiological/Medical 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 dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-P