Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion

[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 [www.gpo.gov]
[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, 
Shu-Chen.Peng@fda.hhs.gov.

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;
•  Skin burn                         Human factors testing;
•  Skin redness                      Software verification,
•  Skin irritation                    validation, and hazard
•  Facial muscle twitching            analysis;
•  Electrical shock                  Electrical safety testing;
•  Pain                              Electromagnetic compatibility
•  Headache                           testing;
•  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