Rule2022-02368
Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Microorganisms and Antimicrobial Resistance Using Reporter Expression
Primary source
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Published
February 4, 2022
Effective
February 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the system for detection of microorganisms and antimicrobial resistance using reporter expression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the system for detection of microorganisms and antimicrobial resistance using reporter expression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6415-6417]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02368]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2021-N-0807]
Medical Devices; Immunology and Microbiology Devices;
Classification of the System for Detection of Microorganisms and
Antimicrobial Resistance Using Reporter Expression
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the system for detection of microorganisms and antimicrobial resistance
using reporter expression into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the system for detection of
microorganisms and antimicrobial resistance using reporter expression's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.
DATES: This order is effective February 4, 2022. The classification was
applicable on December 5, 2019.
FOR FURTHER INFORMATION CONTACT: Tobin Hellyer, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3272, Silver Spring, MD 20993-0002, 301-796-6154,
<a href="/cdn-cgi/l/email-protection#5e0a313c373070163b3232273b2c1e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="cb9fa4a9a2a5e583aea7a7b2aeb98badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the system for detection of
microorganisms and antimicrobial resistance using reporter expression
as class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation by placing the device into a lower device class than the
automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a
[[Page 6416]]
common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)s (see
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or premarket approval application to
market a substantially equivalent device (see 21 U.S.C. 360c(i),
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On March 19, 2019, FDA received Roche Molecular Systems, Inc.'s
request for De Novo classification of the cobas vivoDx MRSA. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on December 5, 2019, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
866.1655.\1\ We have named the generic type of device system for
detection of microorganisms and antimicrobial resistance using reporter
expression, and it is identified as an in vitro diagnostic device
intended for the detection and identification of live microorganisms
and the detection of associated antimicrobial drug susceptibility or
resistance in specimens from patients at risk of colonization or
suspected of infection.
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\1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--System for Detection of Microorganisms and Antimicrobial
Resistance Using Reporter Expression Risks and Mitigation Measures
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Identified risks Mitigation measures
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Failure to use the device correctly.... Certain labeling information
identified in special controls
(b)(1) and (3), and Certain
design verification and
validation identified in
special control (b)(4)(vii).
False positive or negative results..... Certain labeling information
identified in special controls
(b)(1) and (3), Use of certain
specimen collection and
transport devices identified
in special control (b)(2), and
Certain design verification
and validation identified in
special control (b)(4).
Failure to interpret results correctly. Certain labeling information
identified in special controls
(b)(1) and (3), and Certain
design verification and
validation identified in
special control (b)(4)(vii).
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget
[[Page 6417]]
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The collections of information in the guidance document ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801 and 809 regarding labeling, have been
approved under OMB control number 0910-0485.
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, 360l, 371.
0
2. Add Sec. 866.1655 to subpart B to read as follows:
Sec. 866.1655 System for detection of microorganisms and
antimicrobial resistance using reporter expression.
(a) Identification. A system for detection of microorganisms and
antimicrobial resistance using reporter expression is an in vitro
diagnostic device intended for the detection and identification of live
microorganisms and the detection of associated antimicrobial drug
susceptibility or resistance in specimens from patients at risk of
colonization or suspected of infection.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The intended use for the device in the labeling required under
Sec. 809.10 of this chapter must include a detailed description of the
targets the device detects, the type of results provided to the user,
the clinical indications appropriate for test use, and the specific
population(s) for which the device is intended.
(2) Any device used for specimen collection and transport must be
FDA-cleared, approved, or -classified as 510(k) exempt (standalone or
as part of a test system) for the collection of the specimen types
claimed by this device and for the maintenance of viability of the
targeted microorganisms; alternatively, the specimen collection device
must be cleared in a premarket submission as a part of this device.
(3) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) A detailed description of the device, including reagents,
instruments, ancillary materials, applicable specimen collection and
transport device(s) and control elements, and a detailed explanation of
the methodology, including all pre-analytical methods for handling and
processing of specimens and controls to maintain organism viability;
(ii) Detailed descriptions of the test procedure, including the
preparation and maintenance of quality controls and the interpretation
of test results;
(iii) Detailed discussion of the performance characteristics of the
device for all claimed organisms and specimen types based on analytical
studies, including evaluation of analytical sensitivity, inclusivity,
cross-reactivity, potentially interfering substances and
microorganisms, contamination, specimen stability, precision, and
reproducibility;
(iv) Detailed discussion of the performance characteristics of the
device observed in a clinical study performed on a population that is
consistent with the intended use population in comparison to the
results obtained by a reference or comparator method determined to be
acceptable by FDA, for microbial detection, identification, and
antimicrobial susceptibility testing; and
(v) A limiting statement indicating that a negative test result
does not preclude colonization or infection with organisms that do not
express detectable levels of the reporter that is identified by the
device.
(4) Design verification and validation must include:
(i) A detailed description of the device, including an explanation
of the technology, hardware, software, and consumables, as well as an
explanation of the result algorithms and method(s) of data processing
from signal acquisition to result assignment;
(ii) A detailed description of the impact of any software,
including software applications and hardware-based devices that
incorporate software, on the device's functions;
(iii) Detailed documentation of the analytical and clinical studies
required in paragraphs (b)(3)(iii) and (iv) of this section, including
the study protocols containing descriptions of the test methods,
prescribed methods of data analysis and acceptance criteria, final
study reports, and data line listings;
(iv) Detailed documentation of quality control procedures,
including an explanation of how quality control materials were
selected, the recommended frequency of testing, methods of control
preparation, acceptance criteria for performance and the results from
quality control testing performed during the analytical and clinical
studies required under paragraphs (b)(3)(iii) and (iv) of this section;
(v) Detailed documentation of studies performed to establish
onboard and in-use reagent stability, including the test method(s),
data analysis plans, acceptance criteria, final study reports, and data
line listings;
(vi) Detailed documentation of studies to establish reagent shelf-
life for the assay kit and each applicable specimen collection and
transport device, including study protocols containing descriptions of
the test method(s), data analysis plans, and acceptance criteria; and
(vii) Documentation of an appropriate end user device training
program that will be offered as part of efforts to assure appropriate
conduct of the assay and to mitigate the risk associated with false
results, including failure to use the device correctly or correctly
interpret results.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02368 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P
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