Rule2026-10675
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
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Published
May 29, 2026
Effective
May 29, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms 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 to treat fibromyalgia symptoms. 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 103 (Friday, May 29, 2026)</title>
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[Federal Register Volume 91, Number 103 (Friday, May 29, 2026)]
[Rules and Regulations]
[Pages 31896-31898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10675]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2026-N-5197]
Medical Devices; Neurological Devices; Classification of the
Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia
Symptoms
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
transcutaneous electrical nerve stimulator to treat fibromyalgia
symptoms 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 to treat fibromyalgia symptoms. 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 May 29, 2026. The classification was
applicable on May 18, 2022.
FOR FURTHER INFORMATION CONTACT: Chun Xu, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4256, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#6d2e0518034335182d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="93d0fbe6fdbdcbe6d3f5f7f2bdfbfbe0bdf4fce5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the
transcutaneous electrical nerve stimulator to treat fibromyalgia
symptoms into class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness of the
device. 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 into, 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
classification 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 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.
[[Page 31897]]
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 October 5, 2021, FDA received NeuroMetrix, Inc.'s request for De
Novo classification of the Quell-FM 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 of the device, 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 May 18, 2022, 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
882.5888.\1\ We have named the generic type of device ``transcutaneous
electrical nerve stimulator to treat fibromyalgia symptoms,'' and it is
identified as a prescription device that transcutaneously stimulates a
patient's sensory nerves through electrodes placed on the skin to treat
fibromyalgia symptoms.
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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 risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Transcutaneous
Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
Skin discomfort, burns, electrical Electromagnetic compatibility
shock, or pain at stimulation site. testing; Electrical,
mechanical, and thermal safety
testing; Non-clinical
performance testing; Software
verification, validation, and
hazard analysis; and Labeling.
Device failure due to interference with Electromagnetic compatibility
other devices. testing; Software
verification, validation, and
hazard analysis; and Labeling.
Delayed or ineffective treatment due to Labeling.
user error.
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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 of the device. 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.
At the time of classification, transcutaneous electrical nerve
stimulators to treat fibromyalgia symptoms are 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.
Under the FD&C Act, submission of a premarket notification under
section 510(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 transcutaneous electrical
nerve stimulators to treat fibromyalgia symptoms. 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 normally 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 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 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. 882.5888 to subpart F to read as follows:
[[Page 31898]]
Sec. 882.5888 Transcutaneous electrical nerve stimulator to treat
fibromyalgia symptoms.
(a) Identification. A transcutaneous electrical nerve stimulator to
treat fibromyalgia symptoms is a prescription device that
transcutaneously stimulates a patient's sensory nerves through
electrodes placed on the skin to treat fibromyalgia symptoms.
(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. This
testing must include:
(i) Characterization of the electrical stimulation parameters,
including the following: waveforms; output modes; maximum output
voltage and maximum output current (at 500[Omega], 2k[Omega], and
10k[Omega] loads); pulse duration; frequency; net charge per pulse;
maximum phase charge, maximum current density, maximum average current,
and maximum average power density (at 500[Omega]);
(ii) Characterization of the impedance monitoring system; and
(iii) Characterization of electrode performance, including the
electrical performance, adhesive integrity, shelf life, reusability,
and current distribution of the electrode surface area.
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and
mechanical safety along with electromagnetic compatibility of the
device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) Labeling must include the following:
(i) Recommended treatment regimes, including but not limited to,
frequency and duration of use, application site(s), and typical
sensations experienced during treatment;
(ii) A shelf life for the electrode and reuse information;
(iii) Summaries of the electrical stimulation parameters and device
technical parameters (including any wireless specifications); and
(iv) Instructions on how to correctly use and maintain the device,
including all user-interface components.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10675 Filed 5-28-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 29, 2026.
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