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[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Rules and Regulations]
[Pages 49100-49102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23022]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5290]

Medical Devices; Immunology and Microbiology Devices; 
Classification of the Mass Spectrometer System for Clinical Use for the 
Identification of Microorganisms

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the mass spectrometer system for clinical use for the identification of 
microorganisms 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 mass spectrometer system for 
clinical use for the identification of microorganisms' 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, in part by reducing regulatory burdens.

DATES: This order is effective October 24, 2017. The classification was 
applicable on August 21, 2013.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the mass spectrometer system for 
clinical use for the identification of microorganisms 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, in part 
by reducing regulatory burdens 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 (the 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification, 
a 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 shall 
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, in part by reducing regulatory 
burdens. 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 (PMA) in order 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 January 3, 2013, bioM[eacute]rieux, Inc. submitted a request for 
De Novo classification of the Vitek[supreg] MS. 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 general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.

[[Page 49101]]

    Therefore, on August 21, 2013, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 866.3361. We have named 
the generic type of device mass spectrometer system for clinical use 
for the identification of microorganisms, and it is identified as a 
qualitative in vitro diagnostic device intended for the identification 
of microorganisms cultured from human specimens. The device is 
comprised of an ionization source, a mass analyzer, and a spectral 
database. The device is indicated for use in conjunction with other 
clinical and laboratory findings to aid in the diagnosis of bacterial 
and fungal infections.
    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--Mass Spectrometer System for Clinical Use for the
     Identification of Microorganisms Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Incorrect identification of a            (1) Premarket notification
 pathogenic microorganism can lead to     submissions must include
 improper patient management.             detailed documentation for
                                          device software, including,
                                          but not limited to, standalone
                                          software applications and
                                          hardware-based devices that
                                          incorporate software.
                                         (2) Premarket notification
                                          submissions must include
                                          database implementation
                                          methodology, construction
                                          parameters, and quality
                                          assurance protocols.
Failure to correctly interpret test      (1) A detailed explanation of
 results.                                 the interpretation of results
                                          and acceptance criteria must
                                          be included in the device's 21
                                          CFR 809.10(b)(9) compliant
                                          labeling.
Failure to correctly operate the         (1) As part of the risk
 instrument.                              management activities
                                          performed as part of your 21
                                          CFR 820.30 design controls,
                                          you must document an
                                          appropriate end user device
                                          training program that will be
                                          offered as part of your
                                          efforts to mitigate the risk
                                          of failure to correctly
                                          operate the instrument.
                                         (2) Premarket notification
                                          submissions must include
                                          details on the appropriate end
                                          user device training program
                                          that will be offered while
                                          marketing the device.
------------------------------------------------------------------------

    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. In order 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. The device is subject to premarket 
notification requirements under section 510(k).

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. 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 
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 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.  866.3361 to subpart D to read as follows:

Sec.  866.3361  Mass spectrometer system for clinical use for the 
identification of microorganisms.

    (a) Identification. A mass spectrometer system for clinical use for 
the identification of microorganisms is a qualitative in vitro 
diagnostic device intended for the identification of microorganisms 
cultured from human specimens. The device is comprised of an ionization 
source, a mass analyzer, and a spectral database. The device is 
indicated for use in conjunction with other clinical and laboratory 
findings to aid in the diagnosis of bacterial and fungal infections.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed 
documentation for device software, including, but not limited to, 
standalone software applications and hardware-based devices that 
incorporate software.
    (2) Premarket notification submissions must include database 
implementation methodology, construction parameters, and quality 
assurance protocols.
    (3) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 
809.10(b)(9) compliant labeling.
    (4) As part of the risk management activities performed as part of 
your 21 CFR 820.30 design controls, you must document an appropriate 
end user device training program that will be offered as part of your 
efforts to mitigate the risk of failure to correctly operate the 
instrument.

[[Page 49102]]

    (5) Premarket notification submissions must include details on the 
appropriate end user device training program that will be offered while 
marketing the device.

    Dated: October 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23022 Filed 10-23-17; 8:45 am]
BILLING CODE 4164-01-P
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