Rule2024-19725
Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 3, 2024
Effective
September 3, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19725]
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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.
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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.
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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,
<a href="/cdn-cgi/l/email-protection#63220d0a17024d21060f020d0a230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="40012e2934216e02252c212e29002624216e2828336e272f36">[email protected]</span></a>.
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.
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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--Neuromuscular Tongue Muscle Stimulator for the Reduction of
Snoring and Obstructive Sleep Apnea Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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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.
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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 (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
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