Rule2025-23413
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
Primary source
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Published
December 19, 2025
Effective
December 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits 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 classification of the electrical tongue nerve stimulator to treat motor deficits. We are taking this action because we have determined that classifying the device into class II 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.
Full Text
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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Rules and Regulations]
[Pages 59377-59379]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2025-N-6025]
Medical Devices; Neurological Devices; Classification of the
Electrical Tongue Nerve Stimulator To Treat Motor Deficits
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the electrical tongue nerve stimulator to treat motor
deficits 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 classification of the electrical
tongue nerve stimulator to treat motor deficits. We are taking this
action because we have determined that classifying the device into
class II 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.
[[Page 59378]]
DATES: This order is effective December 19, 2025. The classification
was applicable on March 25, 2021.
FOR FURTHER INFORMATION CONTACT: Ozell Sanders, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4524, Silver Spring, MD 20993-0002, 301-796-3126,
<a href="/cdn-cgi/l/email-protection#105f6a757c7c3e43717e74756263507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="733c09161f1f5d20121d17160100331517125d1b1b005d141c05">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the electrical tongue nerve
stimulator to treat motor deficits 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 (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.
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 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
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On August 4, 2020, FDA received Helius Medical Inc.'s request for
De Novo classification of the Portable Neuromodulation Stimulator
(PoNS). 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 section 513(a)(1)(B) of the FD&C Act). 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 March 25, 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
882.5889.\1\ We have named the generic type of device ``electrical
tongue nerve stimulator to treat motor deficits,'' and it is identified
as a prescription device that consists of a non-implantable apparatus
to generate electrical pulses for stimulation of the nerves in the
tongue to provide treatment of motor deficits.
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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--Electrical Tongue Nerve Stimulator To Treat Motor Deficits
Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
[[Page 59379]]
Thermal, electrical, or mechanical Electrical, mechanical, and
fault, or system malfunction resulting thermal safety testing;
in tissue damage due to Electromagnetic compatibility
overstimulation or thermal injury testing; Battery safety
(e.g., burn/shock) to user. testing; Non-clinical
performance testing; Software
validation, verification and
hazard analysis; and Labeling.
Use error that may result in user Labeling.
discomfort or injury.
Device contamination resulting in Labeling.
patient illness.
Adverse events involving the mouth, Labeling.
tongue, or gums such as irritation and
discomfort.
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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 final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) (21 U.S.C. 360(k)) is required to reasonably assure the
safety and effectiveness of class II devices unless FDA determines that
the device type should be exempt under section 510(m). At this time FDA
has not made this determination for electrical tongue nerve stimulators
to treat motor deficits. This device is therefore subject to premarket
notification requirements under section 510(k) of the FD&C Act.
At the time of classification, the electrical tongue nerve
stimulator to treat motor deficits is 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.
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
parts 801 regarding labeling have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 882
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
882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 882.5889 to subpart F to read as follows:
Sec. 882.5889 Electrical tongue nerve stimulator to treat motor
deficits.
(a) Identification. An electrical tongue nerve stimulator to treat
motor deficits is a prescription device that consists of a non-
implantable apparatus to generate electrical pulses for stimulation of
the nerves in the tongue to provide treatment of motor deficits.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Performance data must demonstrate that all patient-contacting
components of the device are biocompatible.
(2) Performance data must demonstrate the electromagnetic
compatibility, battery safety, and electrical, mechanical, and thermal
safety of the device.
(3) Non-clinical performance testing must characterize the
electrical stimulation parameters of the device.
(4) Software verification, validation, and hazard analysis must be
performed. Software documentation must include an assessment of the
impact of threats and vulnerabilities on device functionality and end
users as part of cybersecurity review.
(5) Labeling must include:
(i) A detailed summary of the device's technical parameters;
(ii) Instructions for use;
(iii) Cleaning, storage, and charging instructions; and
(iv) Disposal instructions.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23413 Filed 12-18-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 19, 2025.
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