Rule2026-10894
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
Primary source
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Published
June 1, 2026
Effective
June 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator 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 oropharyngeal electrical stimulator. 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 104 (Monday, June 1, 2026)</title>
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[Federal Register Volume 91, Number 104 (Monday, June 1, 2026)]
[Rules and Regulations]
[Pages 32345-32347]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10894]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. FDA-2026-N-5723]
Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Oropharyngeal Electrical Stimulator
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
oropharyngeal electrical stimulator 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 oropharyngeal electrical stimulator. 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 June 1, 2026. The classification was
applicable on September 16, 2022.
FOR FURTHER INFORMATION CONTACT: Sunny Park, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1266, Silver Spring, MD 20993-0002, 301-796-7059,
<a href="/cdn-cgi/l/email-protection#90c3e5fefee9bec0f1e2fbd0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="a8fbddc6c6d186f8c9dac3e8ceccc986c0c0db86cfc7de">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the
oropharyngeal electrical stimulator 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. 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 April 19, 2022, FDA received Phagenesis Limited's request for De
Novo classification of the Phagenyx System. 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
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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 September 16, 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
874.5950.\1\ We have named the generic type of device ``oropharyngeal
electrical stimulator,'' and it is identified as a device that
stimulates afferent nerve fibers of oropharyngeal mucosa. The device is
intended to treat swallowing dysfunction. The device may incorporate a
feeding tube.
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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 Oropharyngeal
Electrical Stimulators
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Identified risks to health Mitigation measures
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Incorrect stimulation output leading to Non-clinical performance
discomfort or delayed treatment, or testing; Software
incorrect location of stimuli leading verification, validation and
to jaw chattering or facial/ear pain. hazard analysis; Usability
testing; and Training.
Off target neurostimulation due to Usability testing; and
patient specific injury resulting in Training.
harmful neurological activity.
Tissue damage due to mechanical stress, Usability testing; Training;
electrical effects, or heating effects. and Electrical safety testing.
Electrical shock from electrical Non-clinical performance
component malfunction. testing; and Electrical safety
testing.
Interference with other devices leading Electromagnetic compatibility
to malfunction or injury. testing.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Sterilization validation;
Reprocessing validation; Shelf
life testing; and Labeling.
Software failure leading to delayed Software verification,
treatment or discomfort. validation and hazard
analysis.
Fire hazard in the presence of Non-clinical performance
supplementary oxygen. testing; and Training.
For devices with feeding tubes, leakage Non-clinical performance
and misplacement of feeding tube testing; Training; and
leading to feeding-related Usability testing.
complications (e.g., temporary
suboptimal nutrition, reflux
aspiration, respiratory distress).
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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.
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 oropharyngeal electrical
stimulators. 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 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. 874.5950 to subpart F to read as follows:
Sec. 874.5950 Oropharyngeal electrical stimulator.
(a) Identification. An oropharyngeal electrical stimulator is a
device that stimulates afferent nerve fibers of oropharyngeal mucosa.
The device is intended to treat swallowing dysfunction. The device may
incorporate a feeding tube.
(b) Classification. Class II (special controls). The special
controls for this device are:
[[Page 32347]]
(1) Non-clinical performance testing must demonstrate the device
performs as intended under anticipated conditions of use, including the
following:
(i) Electrical output testing;
(ii) Mechanical integrity testing of electrical components;
(iii) Testing to verify safe use of the electrical stimulator
component in the presence of supplementary oxygen; and
(iv) If the device incorporates a feeding tube, feeding tube
functionality testing, including mechanical integrity, liquid leakage,
flow rate and connector compatibility.
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance testing must demonstrate the sterility of the
components intended to be provided sterile.
(4) Performance data must validate the reprocessing instructions
for any reusable components of the device.
(5) Performance testing must support the shelf life of the device
by demonstrating continued sterility, package integrity, and device
functionality over the labeled shelf life.
(6) Software verification, validation and hazard analysis must be
performed for any software components of the device.
(7) Performance testing must demonstrate the electromagnetic
compatibility and electrical safety of any electrical components.
(8) A training program must be included with sufficient educational
elements so that upon completion of the training program, the user can
correctly operate the device.
(9) Usability testing must demonstrate that the device can be
correctly used as per training and labeling.
(10) The labeling must include a shelf life for any sterile
components.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10894 Filed 5-29-26; 8:45 am]
BILLING CODE 4164-01-P
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