[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Rules and Regulations]
[Pages 31023-31028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2013-N-0544]
Microbiology Devices; Reclassification of Nucleic Acid-Based
Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying
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). FDA is also
issuing the special controls guideline entitled ``Class II Special
Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens.'' These devices are intended to be used as an aid in the
diagnosis of pulmonary tuberculosis.
DATES: This rule is effective June 30, 2014.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0544, 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:
Mail/Hand delivery/Courier (for paper 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-2013-N-0544 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), the
Food and Drug Administration Modernization Act of 1997 (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), the Food and Drug Administration Amendments Act of 2007 (Pub.
L. 110-85), and the Food and Drug Administration Safety and Innovation
Act (Pub. L. 112-144) 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) establishes 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
[[Page 31024]]
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 of the regulations (21 CFR part 807). Section 510(k) of the
FD&C Act and the implementing regulations in 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 FDA classifies the
device into class I or class II by issuing 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 or the device is reclassified into class I or class II. 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.
Section 513(f)(2) of the FD&C Act establishes procedures for ``de
novo'' risk-based review and classification of postamendment devices
automatically classified into class III by section 513(f)(1). Under
these procedures, any person whose device is automatically classified
into class III by section 513(f)(1) of the FD&C Act may seek
reclassification into class I or II, either after receipt of an order
finding the device to be not substantially equivalent, in accordance
with section 513(i), to a predicate device that does not require
premarket approval, or at any time after determining there is no
legally marketed device upon which to base a determination of
substantial equivalence. In addition, under section 513(f)(3) of the
FD&C Act, FDA may initiate, or the manufacturer or importer of a device
may petition for, the reclassification of a device classified into
class III under section 513(f)(1).
II. Regulatory Background of the Device
A nucleic acid-based in vitro diagnostic device 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 21
CFR 860.130(a), FDA is reclassifying these devices 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 a 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 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.
IV. Background for Reclassification Decision
At an FDA/Centers for Disease Control (CDC)/National Institute of
Allergy and Infectious Diseases public workshop entitled ``Advancing
the Development of Diagnostic Tests and Biomarkers for Tuberculosis,''
held in Silver Spring, MD, on June 7 and 8, 2010, 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 (Ref. 1).
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 on June 29,
2011. 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. All panel members expressed
the opinion that sufficient data and information exist 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 (Ref. 2). All outside speakers at the open
public hearing session during the meeting also spoke in favor of
reclassification.
No comments were received on the proposed rule issued on June 19,
2013.
V. Classification
FDA is reclassifying nucleic acid-based in vitro diagnostic devices
for the detection of M. tuberculosis complex in respiratory specimens
from class III to class II. FDA believes that reclassifying this device
into class II with special controls (guideline document) provides
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, is not exempting 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 acid-based in
vitro diagnostic devices for the detection of M. tuberculosis complex
in respiratory specimens: (1) False positive test results may lead to
incorrect
[[Page 31025]]
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
health care workers handling specimens and control materials with the
possibility of transmission of tuberculosis infection to health care
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 well-established 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
guideline 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 guideline 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 health care workers handling specimens and
control materials with the possibility of transmission of tuberculosis
infection to health care workers could be addressed similarly to
existing devices of this type that we have already approved. It is
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 guideline 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
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 the measures set forth in the special controls
guideline entitled ``Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens'' are necessary, in addition to general controls, to mitigate
the risks to health described in section VI. As seen in table 1, the
special controls set forth in the guideline for this device address
each of the identified risks.
Table 1--Risks to Health and Mitigation Measures
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Identified risks Mitigation measures
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False positive test results may lead to Device description containing
incorrect treatment of the individual the information specified in
with possible adverse effects. The the special control guideline.
patient may be subjected to Performance studies.
unnecessary isolation and/or other Labeling.
human contact limitations. Unnecessary
contact investigations may also occur.
False negative test results could Device description containing
result in disease progression, and the the information specified in
risk of transmitting disease to others. the special control guideline.
Performance studies.
Labeling.
Biosafety risks to health care workers Labeling.
handling specimens and control
materials with the possibility of
transmission of tuberculosis infection
to health care workers.
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As of the effective date of this rule, nucleic acid-based in vitro
diagnostic devices for the detection of M. tuberculosis complex in
respiratory specimens will be reclassified into class II. The
reclassification will be codified
[[Page 31026]]
in 21 CFR 866.3372. Firms submitting a 510(k) for a nucleic acid-based
in vitro diagnostic device for the detection of M. tuberculosis complex
in respiratory specimens will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls
guideline or (2) use alternative mitigation measures, but demonstrate
to the Agency's satisfaction that alternative measures identified by
the firm will provide at least an equivalent assurance of safety and
effectiveness. Adherence to the criteria in the guideline, in addition
to the general controls, is necessary to provide a reasonable assurance
of the safety and effectiveness of the devices.
IX. Electronic Access to the Special Controls Guideline
Persons interested in obtaining a copy of the guideline may do so
by using the Internet. A search capability for all Center for Devices
and Radiological Health guidelines and guidance documents is available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. The guideline is also available at
http://www.regulations.gov.
To receive ``Class II Special Controls Guideline: 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 guideline you
are requesting.
X. Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this
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. Federalism
FDA has analyzed this final 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 v. Lohr, 518
U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)). The
special controls established by this final rule create ``requirements''
for specific medical devices under 21 U.S.C. 360k, even though product
sponsors have some flexibility in how they meet those requirements.
(See Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)).
XII. Paperwork Reduction Act of 1995
This rule 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.
XIII. Clarifications to Special Controls Guideline
This special controls guideline reflects changes the Agency is
making to clarify its position on the binding nature of special
controls. The changes include referring to the document as a
``guideline,'' as that term is used in section 513(a) of the FD&C Act,
which the Secretary has developed and disseminated to provide a
reasonable assurance of safety and effectiveness for class II devices,
and not a ``guidance,'' as that term is used in 21 CFR 10.115. The
guideline clarifies that firms will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls
guideline or (2) use alternative mitigation measures, but demonstrate
to the Agency's satisfaction that those alternative measures identified
by the firm will provide at least an equivalent assurance of safety and
effectiveness. Finally, the guideline uses mandatory language to
emphasize that firms must comply with special controls to legally
market their class II devices. These revisions do not represent a
change in FDA's position about the binding effect of special controls,
but rather are intended to address any possible confusion or
misunderstanding.
XIV. Analysis of Impacts
FDA has examined the impacts of the final 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 rule is not a significant
regulatory action as defined by 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 reclassification relieves manufacturers
of premarket approval requirements of section 515 of the FD&C Act (21
U.S.C. 360e) it would not create new burdens. Thus, the Agency
certifies that the 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 $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.
The proposed rule was issued on June 19, 2013 (78 FR 36698). The
comment period closed August 19, 2013, and FDA did not receive any
comments. We revise the analysis of impact presented in the proposed
rule with more current data, and adjust for inflation. Our estimate of
benefits annualized over 20 years is $12.34 million at a 3 percent
discount rate and $8.02 million at a 7
[[Page 31027]]
percent discount rate. The change in pre- and post-marketing
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. Table 2 summarizes the estimated costs and benefits.
The full discussion of economic impacts is available in docket FDA-
2013-N-0544 at http://www.regulations.gov, and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref.
4).
Table 2--Summary of Benefits, Costs and Distributional Effects of Final Rule
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Units
---------------------------------
Category Primary Low High Discount Period Notes
estimate estimate estimate Year rate covered
dollars (percent) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized................................. $8.02 ......... ......... 2012 7 20
Monetized $millions/year................... $12.34 ......... ......... 2012 3 20
Annualized................................. ........... ......... ......... 2012 7 20
Quantified................................. ........... ......... ......... 2012 3 20
Qualitative................................
Costs:
Annualized................................. ........... ......... ......... 2012 7 20
Monetized $millions/year................... ........... ......... ......... 2012 3 20
Annualized................................. ........... ......... ......... 2012 7 20
Quantified................................. ........... ......... ......... 2012 3 20
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Qualitative................................ 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.
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Transfers:
Federal.................................... ........... ......... ......... 2012 7 20
Annualized................................. ........... ......... ......... 2012 3 20
--------------------------------------------------------------------------------------------------------
Monetized $millions/year................... From:
To:
--------------------------------------------------------------------------------------------------------
Other...................................... ........... ......... ......... 2012 7 20
Annualized................................. ........... ......... ......... 2012 3 20
--------------------------------------------------------------------------------------------------------
Monetized $millions/year................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None estimated...................................................................................................
Small Business: The proposed rule will not have a significant impact on a substantial number of small entities......................................
Wages: None estimated...............................................................................................................................
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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,
and are available electronically at http://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are 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.)
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, pp. 7-10, January 16,
2009. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm.)
4. Full Disclosure Final Regulatory Impact Analysis of the final
rule ``Microbiology Devices; Reclassification of Nucleic Acid-Based
Systems for Mycobacterium tuberculosis Complex in Respiratory
Specimens,'' Docket No. FDA-2013-N-0544. (Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
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, 21 CFR part
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 866.3372 to subpart D to read as follows:
[[Page 31028]]
Sec. 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 acid-based in vitro diagnostic
devices intended to detect Mycobacterium 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 Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens.'' For availability of the guideline document, see Sec.
866.1(e).
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12544 Filed 5-29-14; 8:45 am]
BILLING CODE 4160-01-P