[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16124-16125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6519]



[[Page 16123]]

Vol. 77

Monday,

No. 53

March 19, 2012

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 866





Draft Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Nucleic Acid-Based In 
Vitro Diagnostic Devices for the Detection of Mycobacterium 
tuberculosis Complex in Respiratory Specimens; Availability; 
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems 
for Mycobacterium tuberculosis Complex; Notice and Proposed Rule

  Federal Register / Vol. 77 , No. 53 / Monday, March 19, 2012 / 
Notices  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0179]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based 
In Vitro Diagnostic Devices for the Detection of Mycobacterium 
tuberculosis Complex in Respiratory Specimens; 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availability of a draft guidance entitled ``Class II Special Controls 
Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for 
the Detection of Mycobacterium tuberculosis Complex in Respiratory 
Specimens.'' This document was developed to support the 
reclassification of nucleic acid-based in vitro diagnostic devices for 
the detection of M. tuberculosis complex in respiratory specimens from 
class III into class II. These devices are intended to be used as an 
aid in the diagnosis of pulmonary tuberculosis. This draft guidance 
document describes a means by which in vitro diagnostic devices for the 
detection of M. tuberculosis complex in respiratory specimens may 
comply with the requirement of special controls for class II devices.

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draft guidance before it begins work on the final version of the 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 June 18, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the 
Detection of Mycobacterium tuberculosis Complex in Respiratory 
Specimens'' 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: Janice Washington, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5554, Silver Spring, MD 20993-0002, (301) 
796-6207.

SUPPLEMENTARY INFORMATION: 

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule to reclassify nucleic acid-based in vitro diagnostic 
devices for the detection of M. tuberculosis complex in respiratory 
specimens into class II (special controls) from class III. Nucleic 
acid-based in vitro diagnostic devices for the detection of M. 
tuberculosis complex in respiratory specimens are qualitative nucleic 
acid-based in vitro diagnostic devices intended to detect M. 
tuberculosis complex nucleic acids extracted from human respiratory 
specimens. These devices are non-multiplexed and intended to be used as 
an aid in the diagnosis of pulmonary tuberculosis when used in 
conjunction with clinical and other laboratory findings. These devices 
do not include devices intended to detect the presence of organism 
mutations associated with drug resistance. Respiratory specimens may 
include sputum (induced or expectorated), bronchial specimens (e.g., 
bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.
    This draft guidance document identifies the proposed classification 
regulation, the product code, and identifies issues of safety and 
effectiveness that require special controls. FDA believes that the 
special controls described in the draft guidance when combined with the 
general controls will be sufficient to provide reasonable assurance of 
the safety and effectiveness of these devices.

II. Significance of Guidance

    FDA believes that adherence to the recommendations described in 
this guidance document, when finalized, in addition to the general 
controls, will provide reasonable assurance of the safety and 
effectiveness of nucleic acid-based in vitro diagnostic devices for the 
detection of M. tuberculosis complex in respiratory specimens 
classified under Sec.  866.3372 (21 CFR 866.3372). If classified as a 
class II device under Sec.  866.3372, nucleic acid-based in vitro 
diagnostic devices for the detection of M. tuberculosis complex in 
respiratory specimens will need to comply with the requirement for 
special controls; manufacturers will need to address the issues 
requiring special controls as identified in the guidance document or by 
some other means that provides equivalent assurances of safety and 
effectiveness.

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 
``Class II Special Controls Guidance Document: Nucleic Acid-Based In 
Vitro Diagnostic Devices for the Detection of Mycobacterium 
tuberculosis Complex in Respiratory Specimens,'' 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 1788 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously 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 56.115 have been approved under 
OMB control number 0910-0130; the collections of information in 21 CFR 
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 812 have been 
approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in 21 CFR part 801 
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is

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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.

    Dated: March 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6519 Filed 3-16-12; 8:45 am]
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