Rule2026-07365
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion
Primary source
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Published
April 16, 2026
Effective
April 16, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for the relief of congestion 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 classification of the transcutaneous electrical nerve stimulator for the relief of congestion. 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 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Rules and Regulations]
[Pages 20348-20350]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07365]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. FDA-2026-N-2959]
Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Transcutaneous Electrical Nerve Stimulator for the Relief of
Congestion
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 transcutaneous electrical nerve stimulator for the
relief of congestion 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 classification of the
transcutaneous electrical nerve stimulator for the relief of
congestion. 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.
DATES: This order is effective April 16, 2026. The classification was
applicable on March 5, 2021.
FOR FURTHER INFORMATION CONTACT: Shu-Chen Peng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002, 301-796-6481,
<a href="/cdn-cgi/l/email-protection#b7e4dfc29af4dfd2d999e7d2d9d0f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="75261d0058361d101b5b25101b12351311145b1d1d065b121a03">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the
transcutaneous electrical nerve stimulator for the relief of congestion
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 (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 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 premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying
[[Page 20349]]
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 February 13, 2020, FDA received Tivic Health Systems Inc.'s
request for De Novo classification of the ClearUP Sinus Relief 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 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 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
874.6000.\1\ We have named the generic type of device ``transcutaneous
electrical nerve stimulator for the relief of congestion,'' and it is
identified as a device that electrically stimulates the skin overlying
the paranasal sinuses to relieve congestion.
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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--Transcutaneous Electrical Nerve Stimulator for the Relief of
Congestion
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Identified risks to health Mitigation measures
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Injury from electrical current on face Non-clinical performance
causing one or more of the following: testing;
<bullet> Skin burn Human factors testing;
<bullet> Skin redness Software verification,
<bullet> Skin irritation validation, and hazard
<bullet> Facial muscle twitching analysis;
<bullet> Electrical shock Electrical safety testing;
<bullet> Pain Electromagnetic compatibility
<bullet> Headache testing;
<bullet> Discomfort or muscle twitching Battery safety testing; and
of the eye Labeling.
Nerve and muscle injury.................. Non-clinical performance
testing;
Electrical safety testing;
and
Software verification,
validation, and hazard
analysis.
Ineffective treatment leading to Labeling.
worsening congestion.
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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) of the FD&C Act.
At this time FDA has not made this determination for the transcutaneous
electrical nerve stimulator for the relief of congestion. This device
is therefore 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,
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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
management 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 874
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
874 is amended as follows:
PART 874--EAR, NOSE, AND THROAT DEVICES
0
1. The authority citation for part 874 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 874.6000 to subpart F to read as follows:
Sec. 874.6000 Transcutaneous electrical nerve stimulator for the
relief of congestion.
(a) Identification. A transcutaneous electrical nerve stimulator
for the relief of congestion is a device that electrically stimulates
the skin overlying the paranasal sinuses to relieve congestion.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including electrical stimulation parameters that must be specified and
verified.
(2) Performance data must demonstrate the electromagnetic
compatibility, battery safety, and electrical safety of the device.
(3) Software verification, validation, and hazard analysis must be
performed.
(4) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(5) Human factors testing must demonstrate that users can
successfully use the device in the intended use environment based
solely on its labeling and instructions for use.
(6) Labeling must include the following:
(i) Instructions for use, including images that demonstrate how to
use the device;
(ii) Device specifications, including the number of channels,
output waveform, stimulation peak voltage and current, pulse duration,
frequency, maximum current density, maximum phase charge, and power
source; and
(iii) Explanations of the user-interface components.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07365 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 16, 2026.
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