[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Rules and Regulations]
[Pages 4998-5000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2019-N-0142]


Medical Devices; Dental Devices; Classification of the Auto 
Titration Device for Oral Appliances

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 auto titration device for oral appliances 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 auto titration device for oral appliances' 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 February 20, 2019. The classification 
was applicable on August 23, 2018.

FOR FURTHER INFORMATION CONTACT: Anita Belani, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G314, Silver Spring, MD 20993-0002, 301-796-3944, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the auto titration device for oral 
appliances 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 (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

[[Page 4999]]

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 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 (Pub. L. 105-115) established the first procedure for De 
Novo classification. Section 607 of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo 
application process by adding a second procedure. 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 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 to market a substantially equivalent 
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence''). 
Instead, sponsors can use the 510(k) process, when necessary, to market 
their device.

II. De Novo Classification

    For this device, FDA issued an order on November 23, 2016, finding 
the MATRx plus not substantially equivalent to a predicate not subject 
to premarket approval application. Thus, the device remained in class 
III in accordance with section 513(f)(1) of the FD&C Act when we issued 
the order.
    On December 21, 2017, Zephyr Sleep Technologies submitted a request 
for De Novo classification of the MATRx plus. 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 August 23, 2018, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 872.5571. We have named 
the generic type of device auto titration device for oral appliances, 
and it is identified as a prescription home use device that determines 
a target position to be used for a final oral appliance for the 
reduction of snoring and mild to moderate obstructive sleep apnea.
    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--Auto Titration Device for Oral Appliances Risks and Mitigation
                                Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Reprocessing validation and
                                          Labeling.
Intraoral/temporomandibular joint        Clinical performance testing;
 injury, irritation, or pain due to:      Human factors assessment; Non-
                                          clinical performance testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; Electrical safety
                                          testing; Electromagnetic
                                          compatibility testing; and
                                          Wireless coexistence testing.
     Use error
     Algorithm-directed
     positioning
     Interference with other
     devices
     Device electrical failure
Incorrect titration level due to use     Human factors assessment and
 error.                                   Labeling.
Disruption of sleep....................  Labeling.
Temporary change in bite or dentition..  Labeling.
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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.
    At the time of classification, auto titration devices for oral 
appliances are for prescription use only. Prescription devices are 
exempt from the requirement for adequate directions for use for the 
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) 
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met 
(referring to 21 U.S.C. 352(f)(1)).

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

[[Page 5000]]

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 (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 820, regarding quality system regulation, 
have been approved under OMB control number 0910-0073; 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; and the collections of information in 21 CFR 
part 801, regarding labeling, have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 872

    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 
872 is amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for part 872 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  872.5571 to subpart F to read as follows:


Sec.  872.5571  Auto titration device for oral appliances.

    (a) Identification. An auto-titration device for oral appliances is 
a prescription home use device that determines a target position to be 
used for a final oral appliance for the reduction of snoring and mild 
to moderate obstructive sleep apnea.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) Performance characteristics of the algorithm; and
    (ii) All adverse events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions for use, 
including the following:
    (i) Validation of the closed loop algorithm;
    (ii) Mechanical integrity over the expected use life;
    (iii) Characterization of maximum force, distance, and speed of 
device movement; and
    (iv) Movement accuracy of intraoral components.
    (3) Performance testing must demonstrate the wireless 
compatibility, electrical safety, and electromagnetic compatibility of 
the device in its intended use environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Performance data must validate the reprocessing instructions 
for any reusable components.
    (7) Patient labeling must include:
    (i) Information on device use, including placement of sensors and 
mouthpieces;
    (ii) A description of all alarms; and
    (iii) Instructions for reprocessing any reusable components.
    (8) A human factors assessment must evaluate simulated use of the 
device in a home use setting.

    Dated: February 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02824 Filed 2-19-19; 8:45 am]
BILLING CODE 4164-01-P