16124 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

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Draft Guidance for Industry and Food 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. 

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availability of a draft guidance entitled 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on the draft guidance by June 18, 2012.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single copies of the draft guidance 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draft guidance to http:// 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 nonmultiplexed 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 acidbased in vitro diagnostic devices for the 

detection of M. tuberculosis complex in 

respiratory specimens classified under 

§ 866.3372 (21 CFR 866.3372). If 

classified as a class II device under 

§ 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 AcidBased In Vitro Diagnostic Devices for 

the Detection of Mycobacterium 

tuberculosis Complex in Respiratory 

Specimens,’’ 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 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 


emcdonald on DSK29S0YB1PROD with NOTICES2
Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 16125 

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] 

BILLING CODE 4160–01–P 


emcdonald on DSK29S0YB1PROD with NOTICES2