16126 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2012–N–0159] 

Microbiology Devices; Reclassification 

of Nucleic Acid-Based Systems for 

Mycobacterium tuberculosis Complex 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify nucleic acid-based in vitro 

diagnostic devices for the detection of 

Mycobacterium tuberculosis complex in 

respiratory specimens from class III 

(premarket approval) into class II 

(special controls). These devices are 

intended to be used as an aid in the 

diagnosis of pulmonary tuberculosis. 

DATES: Submit either electronic or 

written comments by June 18, 2012. See 

section IX of this document for the 

proposed effective date of any final rule 

that may publish based on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0159, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2012–N–0159 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Janice A. 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. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), and the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA) (Pub. L. 105–115), 

the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250), the Medical Devices Technical 

Corrections Act (Pub. L. 108–214), and 

the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), establish a comprehensive system 

for the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under the FD&C Act, FDA clears or 

approves the three classes of medical 

devices for commercial distribution in 

the United States through three 

regulatory processes: Premarket 

approval (PMA), product development 

protocol, and premarket notification (a 

premarket notification is generally 

referred to as a ‘‘510(k)’’ after the section 

of the FD&C Act where the requirement 

is found). The purpose of a premarket 

notification is to demonstrate that the 

new device is substantially equivalent 

to a legally-marketed predicate device. 

Under section 513(i) of the FD&C Act, 

a device is substantially equivalent if it 

has the same intended use and 

technological characteristics as a 

predicate device, or has different 

technological characteristics but data 

demonstrate that the new device is as 

safe and effective as the predicate 

device and does not raise different 

issues of safety or effectiveness. 

FDA determines whether new devices 

are substantially equivalent to 

previously offered devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and part 807 (21 CFR part 

807) of the regulations. Section 510(k) of 

the FD&C Act and the implementing 

regulation part 807, subpart E, require a 

person who intends to market a medical 

device to submit a premarket 

notification submission to FDA before 

proposing to begin the introduction, or 

delivery for introduction into interstate 

commerce, for commercial distribution 

of a device intended for human use. 

In accordance with section 513(f)(1) of 

the FD&C Act, devices that were not in 

commercial distribution before May 28, 

1976, the date of enactment of the 1976 

amendments, generally referred to as 

postamendment devices, are classified 

automatically by statute into class III 

without any FDA rulemaking process. 

These devices remain in class III and 

require premarket approval, unless the 

device is classified or reclassified into 

class I or class II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act and part 807 of FDA’s 

regulations. 

Devices of a new type that FDA has 

not previously classified based on risk 

are ‘‘automatically’’ or ‘‘statutorily’’ 

classified into class III by operation of 

section 513(f)(1) of the FD&C Act, 

regardless of the level of risk they pose. 

This is because, by definition, a new 

type of device would not be within a 

type that was on the market before the 

1976 Medical Device Amendments or 

that has since been classified into class 

I or class II. Congress enacted section 

513(f)(2) of the FD&C Act as part of 

FDAMA. The process created by this 

provision, which is referred to in 

FDAMA as the Evaluation of Automatic 

Class III Designation, will be referred to 

as the ‘‘de novo process’’. Congress 

included this section to limit 

unnecessary expenditure of FDA and 

industry resources that could occur if 

lower risk devices were subject to 

premarket approval under section 515 of 

the FD&C Act (21 U.S.C. 360e). 

Reclassification of classified 

postamendment devices is governed by 

section 513(f)(3) of the FD&C Act. This 

section provides that FDA may initiate 

the reclassification of a device classified 

into class III based under section 513(e) 

of the FD&C Act. FDA’s regulations in 

§ 860.130 (21 CFR 860.130) set forth the 

procedures for the filing and review of 

a petition for reclassification of such 

class III devices. In order to change the 


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classification of the device, it is 

necessary that the proposed new class 

have sufficient regulatory controls to 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. 

II. Regulatory Background of the Device 

Nucleic acid-based in vitro diagnostic 

devices for the detection of M. 

tuberculosis complex in respiratory 

specimens is a postamendment device 

classified into class III under section 

513(f)(1) of the FD&C Act in 1995. 

Consistent with the FD&C Act and 

FDA’s regulations in § 860.130(a), FDA 

believes that these devices should be 

reclassified from class III into class II 

because there is sufficient information 

from FDA’s accumulated experience 

with these devices to establish special 

controls that can provide reasonable 

assurance of the device’s safety and 

effectiveness. 

III. Identification 

Nucleic acid-based in vitro diagnostic 

devices for the detection of M. 

tuberculosis complex in respiratory 

specimens are qualitative nucleic acidbased 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. 

IV. Background for Reclassification 

Decision 

At an FDA/Centers for Disease 

Control (CDC)/National Institute of 

Allergy and Infectious Diseases (NIAID) 

public workshop entitled ‘‘Advancing 

the Development of Diagnostic Tests 

and Biomarkers for Tuberculosis,’’ held 

in Silver Spring, MD, on June 7 and 8, 

2010 (Ref. 1), the class III designation 

for nucleic acid-based in vitro 

diagnostic devices for the detection of 

M. tuberculosis complex in respiratory 

specimens was raised as a barrier to 

advancing M. tuberculosis diagnostics. 

Based on discussion at the public 

workshop, FDA agreed to consider this 

issue further and subsequently 

convened a meeting of the Microbiology 

Devices Panel of the Medical Devices 

Advisory Committee (Microbiology 

Devices Panel) on June 29, 2011 (Ref. 2). 

Although not a formal reclassification 

meeting, panel members were asked to 

discuss if sufficient risk mitigation was 

possible for FDA to initiate the 

reclassification process from class III to 

class II devices for this intended use 

through the drafting of a special controls 

guidance. The panel was not asked to 

vote on whether actual reclassification 

should occur or to assess whether any 

previously approved device or specific 

device currently under development 

warranted reclassification. 

All panel members expressed the 

opinion that sufficient data and 

information exists such that the risks of 

false positive and false negative results 

can be mitigated to allow a special 

controls guidance to be created that 

would support reclassification from 

class III to class II for nucleic acid-based 

in vitro diagnostic devices for the 

detection of M. tuberculosis complex in 

respiratory specimens. All outside 

speakers at the open public hearing 

session during the meeting also spoke in 

favor of reclassification. 

V. Classification Recommendation 

FDA is proposing that nucleic acidbased in vitro diagnostic devices for the 

detection of M. tuberculosis complex in 

respiratory specimens be reclassified 

from class III to class II. FDA believes 

that class II with special controls 

(guidance document and limitations on 

the distribution) would provide 

reasonable assurance of the safety and 

effectiveness of the device. Section 

510(m) of the FD&C Act provides that a 

class II device may be exempt from the 

premarket notification requirements 

under section 510(k), if the Agency 

determines that premarket notification 

is not necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. For this device, FDA 

believes that premarket notification is 

necessary to provide reasonable 

assurance of safety and effectiveness 

and, therefore, does not intend to 

exempt the device from the premarket 

notification requirements. 

VI. Risks to Health 

After considering the information 

discussed by the Microbiology Devices 

Panel during the June 29, 2011, meeting, 

the published literature, and the 

Medical Device Reporting system 

reports, FDA believes the following 

risks are associated with nucleic acidbased in vitro diagnostic devices for the 

detection of M. tuberculosis complex in 

respiratory specimens: (1) False positive 

test results may lead to incorrect 

treatment of the individual with 

possible adverse effects. The patient 

may be subjected to unnecessary 

isolation and/or other human contact 

limitations. Unnecessary contact 

investigations may also occur; (2) False 

negative test results could result in 

disease progression, and the risk of 

transmitting disease to others; and (3) 

Biosafety risks to healthcare workers 

handling specimens and control 

materials with the possibility of 

transmission of tuberculosis infection to 

healthcare workers. 

VII. Summary of the Reasons for 

Reclassification 

FDA, consistent with the opinions 

expressed by the Microbiology Devices 

Panel of the Medical Devices Advisory 

Committee, believes that the 

establishment of special controls, in 

addition to general controls, provides 

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. 

1. The safety and effectiveness of 

nucleic acid-based systems for M. 

tuberculosis complex have become wellestablished since approval of the first 

device for this use in 1995. 

2. The risk of false positive test results 

can be mitigated by specifying 

minimum performance standards in the 

special controls guidance and including 

information regarding patient 

populations appropriate for testing in 

the device labeling. Additional risk 

mitigation strategies include the 

indication for use that the device be 

used as an aid to the diagnosis of 

pulmonary tuberculosis in conjunction 

with other clinical and laboratory 

findings. The device also should be 

accurately described and have labeling 

that addresses issues specific to these 

types of devices. 

3. The risk of false negative test 

results can be mitigated by specifying 

minimum performance standards for 

test sensitivity in the special controls 

guidance and ensuring that different 

patient populations are included in 

clinical trials. Additional risk mitigation 

strategies include the indication for use 

that the device be used as an aid to the 

diagnosis of pulmonary tuberculosis in 

conjunction with other clinical and 

laboratory findings. The device also 

should be accurately described and have 

appropriate labeling that addresses 

issues specific to these types of devices. 

4. Biosafety risks to healthcare 

workers handling specimens and 

control materials with the possibility of 

transmission of tuberculosis infection to 

healthcare workers could be addressed 

similarly to existing devices of this type 

that we have already approved. It is 


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16128 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Proposed Rules 

believed there are no additional 

biosafety risks introduced by 

reclassification from class III to class II. 

The need for appropriate biosafety 

measures can be addressed in labeling 

recommendations that are included in 

the special controls guidance and by 

adherence to recognized laboratory 

biosafety procedures. 

Based on FDA’s review of published 

literature, the information presented by 

outside speakers invited to the 

Microbiology Devices Panel meeting, 

and the opinions of panel members 

expressed at that meeting, FDA believes 

that there is a reasonable basis to 

determine that nucleic acid-based in 

vitro diagnostic devices for the 

detection of M. tuberculosis complex in 

respiratory specimens can provide the 

significant benefit of rapid detection of 

infection in patients with suspected 

tuberculosis as compared to traditional 

means of diagnosis. For patients with 

acid-fast smear negative tuberculosis, 

nucleic acid-based in vitro diagnostic 

devices for the detection of M. 

tuberculosis complex in respiratory 

specimens are currently the only 

laboratory tests available for rapid 

detection of active pulmonary 

tuberculosis. Rapid identification of 

patients with active tuberculosis may 

have significant benefits to the infected 

patient by earlier diagnosis and 

management as well as potentially 

significant effects on the public health 

by limiting disease spread. 

Nucleic acid-based in vitro diagnostic 

devices for the detection of M. 

tuberculosis complex in respiratory 

specimens have been approved for 

marketing by FDA for over 15 years. 

There is substantial scientific and 

medical information available regarding 

the nature, complexity, and problems 

associated with these devices. Revised 

public health recommendations for use, 

published by CDC on January 16, 2009, 

recommended the use of nucleic acid 

amplification testing in conjunction 

with acid-fast microscopy and culture 

and specifically states that ‘‘Nucleic 

acid amplification testing should be 

performed on at least one respiratory 

specimen from each patient with signs 

and symptoms of pulmonary 

[tuberculosis] for whom a diagnosis of 

[tuberculosis] is being considered but 

has not yet been established, and for 

whom the test result would alter case 

management or [tuberculosis] control 

activities’’ (Ref. 3). 

VIII. Special Controls 

FDA believes that, in addition to 

general controls, the proposed special 

controls discussed in this document are 

adequate to address the risks to health. 

FDA believes that the draft guidance 

document entitled ‘‘Nucleic Acid-Based 

In Vitro Diagnostic Devices for the 

Detection of Mycobacterium 

tuberculosis Complex in Respiratory 

Specimens,’’ will address the risks 

previously identified in this document 

and provide a reasonable assurance of 

safety and effectiveness of the device. 

The class II special controls guidance 

document provides information on how 

to meet premarket (510(k)) submission 

requirements for the device in sections 

that discuss analytical performance 

studies, performance studies using 

clinical specimens, and labeling. FDA 

believes that the class II special controls 

guidance document, which incorporates 

analytical studies, performance 

standards, and labeling statements and 

recommendations, minimizes risks to 

health and provides reasonable 

assurance of device safety and 

effectiveness. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability of this class II special 

controls guidance document that the 

Agency intends to use for this device. 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES

Identified risks Recommended mitigation measures 

False positive test results may lead to incorrect treatment of the individual with possible adverse effects. The 

patient may be subjected to unnecessary isolation and/or other human contact limitations. Unnecessary 

contact investigations may also occur. 

Device Description 

Performance Studies 

Labeling. 

False negative test results could result in disease progression and the risk of transmitting disease to others. Device Description 

Performance Studies 

Labeling. 

Biosafety risks to healthcare workers handling specimens and control materials with the possibility of transmission of tuberculosis infection to healthcare workers. Labeling. 

IX. Proposed Effective Date 

FDA proposes that any final rule 

based on this proposal become effective 

30 days after its date of publication in 

the Federal Register. 

X. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this proposed 

reclassification action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

XI. Analysis of Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct Agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The Agency 

believes that this proposed rule is not a 

significant regulatory action as defined 

by the Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the proposed rule 

would create no new burdens, the 

Agency proposes to certify that the final 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 


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million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

Our estimate of benefits annualized 

over 20 years is $9.4 million at a 3- 

percent discount rate and $7.4 million 

at a 7-percent discount rate. The change 

in pre and postmarketing requirements 

between a 510(k) and a PMA lead to 

benefits in the form of reduced 

submission costs, review-related 

activities, and inspections. Another 

unquantifiable benefit from the rule is 

that a decrease in entry could lead to 

further product innovation. FDA is 

unable to quantify the costs that could 

arise if there is a change in risk which 

could lead to adverse events, recalls, 

warning letters, or unlisted letters. 

The full discussion of economic 

impacts (Ref. 4) is available in docket 

FDA–2012–N–0159 and at http:// 

www.regulations.gov. 

XII. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive order requires 

Agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

Federal law includes an express 

preemption provision that preempts 

certain state requirements ‘‘different 

from or in addition to’’ certain Federal 

requirements applicable to devices. (See 

section 521 of the FD&C Act (21 U.S.C. 

360k); Medtronic, Inc. v. Lohr, 518 U.S. 

470 (1996); and Riegel v. Medtronic, Inc. 

128 S. Ct. 999 (2008)). If this proposed 

rule is made final, the special controls 

established by the final rule would 

create ‘‘requirements’’ for specific 

medical devices under 21 U.S.C. 360(k), 

even though product sponsors have 

some flexibility in how they meet those 

requirements (Cf. Papike v. Tambrands, 

Inc., 107 F.3d 737, 740–742 (9th Cir. 

1997)). 

XIII. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) is not 

required. 

This proposed rule designates a draft 

guidance document as a special control. 

FDA also tentatively concludes that the 

draft special control guidance document 

does not contain new information 

collection provisions that are subject to 

review and clearance by OMB under the 

PRA. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

notice announcing the availability of 

that 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,’’ which 

contains an analysis of the paperwork 

burden for the draft guidance. 

XIV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

XV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Transcript of the Tuberculosis Public 

Workshop, June 7, 2010, (Available at 

http://www.fda.gov/downloads/ 

ScienceResearch/SpecialTopics/ 

CriticalPathInitiative/UpcomingEventsonCPI/ 

UCM289182.doc, accessed on January 25, 

2012). 

2. Transcript of FDA’s Microbiology 

Devices Panel Meeting, June 29, 2011, 

(Available at http://www.fda.gov/downloads/ 

AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

MedicalDevices/ 

MedicalDevicesAdvisoryCommittee/ 

MicrobiologyDevicesPanel/UCM269469.pdf.) 

3. ‘‘Updated Guidelines for the Use of 

Nucleic Acid Amplification Tests in the 

Diagnosis of Tuberculosis,’’ Morbidity and 

Mortality Weekly Report (MMWR), vol. 58(1), 

pp. 7–10, January 16, 2009, (Available at 

http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/mm5801a3.htm, accessed on July 

26, 2011). 

4. Full Disclosure Preliminary Regulatory 

Impact Analysis Initial Regulatory Flexibility 

Analysis Unfunded Mandates Reform Act 

Analysis. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 866 be amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

2. Add § 866.3372 to subpart D to read 

as follows: 

§ 866.3372 Nucleic acid-based in vitro 

diagnostic devices for the detection of 

Mycobacterium tuberculosis complex in 

respiratory specimens. 

(a) Identification. Nucleic acid-based 

in vitro diagnostic devices for the 

detection of Mycobacterium 

tuberculosis complex in respiratory 

specimens are qualitative nucleic acidbased 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. 

(b) Classification. Class II (special 

controls). The special control for this 

device is the FDA 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.’’ For availability 

of the guidance document, see 

§ 866.1(e). 

Dated: March 13, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6518 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 


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