[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Rules and Regulations]
[Pages 71153-71155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19725]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 
 ========================================================================
 

  Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / 
Rules and Regulations  

[[Page 71153]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2024-N-3948]


Medical Devices; Dental Devices; Classification of the 
Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and 
Obstructive Sleep Apnea

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the neuromuscular tongue muscle stimulator for the 
reduction of snoring and obstructive sleep apnea 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 neuromuscular tongue muscle stimulator for the reduction of snoring 
and obstructive sleep apnea'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 September 3, 2024. The classification 
was applicable on February 5, 2021.

FOR FURTHER INFORMATION CONTACT: Anita Belani, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G236, Silver Spring, MD 20993-0002, 301-796-3944, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the neuromuscular tongue muscle 
stimulator for the reduction of snoring and obstructive sleep apnea as 
class II (special controls), which we have determined will provide a 
reasonable assurance of safety and effectiveness.
    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 (see 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 common name for the process authorized under section 513(f)(2) of the 
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). 
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 placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    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 section 513(f)(2)(B)(i) of the FD&C 
Act). 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 section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
510(k) process, when necessary, to market their device.

II. De Novo Classification

    On March 24, 2020, FDA received Signifier Medical Technologies' 
request for De Novo classification of the eXciteOSA without remote 
control, eXciteOSA with remote control device. 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

[[Page 71154]]

assurance of the safety and effectiveness of the device.
    Therefore, on February 5, 2021, 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 
872.5575.\1\ We have named the generic type of device neuromuscular 
tongue muscle stimulator for the reduction of snoring and obstructive 
sleep apnea, and it is identified as a device that consists of a 
removable intraoral mouthpiece that uses electrodes to deliver 
neuromuscular stimulation to the tongue to strengthen tongue 
musculature to reduce snoring and obstructive sleep apnea.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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--Neuromuscular Tongue Muscle Stimulator for the Reduction of
    Snoring and Obstructive Sleep Apnea Risks and Mitigation Measures
------------------------------------------------------------------------
    Identified risks to health               Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction...........  Biocompatibility evaluation.
Interference with other devices/    Electrical safety testing,
 electrical shock.                   Electromagnetic compatibility (EMC)
                                     testing, Battery safety testing,
                                     Wireless coexistence testing, and
                                     Labeling.
Use error leading to pain,          Human factors assessment; Software
 discomfort, or injury.              verification, validation, and
                                     hazard analysis; Electrical safety
                                     testing; and Labeling.
Mucosal or skin overheating or      Software validation, verification,
 burn.                               hazard analysis; Electrical safety
                                     testing; Electromagnetic
                                     compatibility (EMC) testing; and
                                     Labeling.
Infection.........................  Labeling.
------------------------------------------------------------------------

    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 (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections 
of information in part 860, subpart D, regarding De Novo classification 
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 
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.  872.5575 to subpart F to read as follows:


Sec.  872.5575   Neuromuscular tongue muscle stimulator for the 
reduction of snoring and obstructive sleep apnea.

    (a) Identification. A neuromuscular tongue muscle stimulator for 
the reduction of snoring and obstructive sleep apnea consists of a 
removable intraoral mouthpiece that uses electrodes to deliver 
neuromuscular stimulation to the tongue to strengthen tongue 
musculature to reduce snoring and obstructive sleep apnea.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance testing must demonstrate the wireless 
compatibility, electrical safety, battery safety, and electromagnetic 
compatibility of the device in its intended use environment.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Patient labeling must include:
    (i) Information on device components, setup, and use of the device 
including placement of sensors and mouthpieces, and images or 
illustrations;
    (ii) A summary of technical specifications;
    (iii) Instructions on how to clean and maintain the device;
    (iv) A statement that the patient should maintain regular follow up 
visits with dentist and sleep specialist; and
    (v) A statement that patients should have a comprehensive dental 
examination prior to using this device.
    (5) A human factors assessment must evaluate simulated use of the 
device to demonstrate that the user can correctly use device based on 
the labeling and instructions for use.


[[Page 71155]]


    Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19725 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-P