Rule2026-07862
Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement
Primary source
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Published
April 22, 2026
Effective
April 22, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the device for sleep apnea testing based on mandibular movement 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 device for sleep apnea testing based on mandibular movement. 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 77 (Wednesday, April 22, 2026)</title>
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[Federal Register Volume 91, Number 77 (Wednesday, April 22, 2026)]
[Rules and Regulations]
[Pages 21381-21383]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07862]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. FDA-2026-N-3929]
Medical Devices; Anesthesiology Devices; Classification of the
Device for Sleep Apnea Testing Based on Mandibular Movement
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
device for sleep apnea testing based on mandibular movement 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 device for sleep apnea testing based
on mandibular movement. 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 22, 2026. The classification was
applicable on January 7, 2022.
FOR FURTHER INFORMATION CONTACT: Farid Yaghouby, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1227, Silver Spring, MD 20993-0002, 240-402-2520,
<a href="/cdn-cgi/l/email-protection#054364776c612b5c64626d6a70677c456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="642205160d004a3d05030c0b11061d240200054a0c0c174a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device for sleep apnea testing
based on mandibular movement 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
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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 2, 2021, FDA received Sunrise SA's request for De Novo
classification of the Sunrise Sleep Disorder Diagnostic Aid. 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 January 7, 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
868.2376.\1\ We have named the generic type of device ``device for
sleep apnea testing based on mandibular movement,'' and it is
identified as a prescription device intended to aid in evaluation of
sleep apnea during sleep in patients suspected of having sleep
breathing disorders by analyzing sensor readings of mandibular
movement. The device is not intended as a substitute for full
polysomnography nor intended to be used as an apnea monitor.
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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 Device for Sleep
Apnea Testing Based on Mandibular Movement
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Identified risks to health Mitigation measures
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Delayed or incorrect treatment due to Software verification,
erroneous output as a result of validation, and hazard
software malfunction or algorithm analysis; Clinical performance
error. testing; and Labeling.
Delayed or incorrect treatment due to Labeling.
user misinterpretation.
Delayed or incorrect treatment due to Software verification,
sensor failing to provide inputs for validation, and hazard
software to adequately analyze. analysis; Clinical performance
testing; and Labeling.
Electrical shock, burn, or interference Electrical safety testing;
with other devices. Electromagnetic compatibility
testing; and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
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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, devices for sleep apnea testing
based on mandibular movement 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 devices for sleep apnea
testing based on mandibular movement. 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 868
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
868 is amended as follows:
PART 868--ANESTHESIOLOGY DEVICES
0
1. The authority citation for part 868 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 868.2376 to subpart C to read as follows:
Sec. 868.2376 Device for sleep apnea testing based on mandibular
movement.
(a) Identification. A device for sleep apnea testing based on
mandibular movement is a prescription device intended to aid in
evaluation of sleep apnea during sleep in patients suspected of having
sleep breathing disorders by analyzing sensor readings of mandibular
movement. The device is not intended as a substitute for full
polysomnography nor intended to be used as an apnea monitor.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical data must be provided. This assessment must fulfill
the following:
(i) The clinical data must be representative of the intended use
population for the device. Any selection criteria or sample limitations
must be fully described and justified.
(ii) The assessment must demonstrate output consistency using the
expected range of data sources and data quality encountered in the
intended use population and environment.
(iii) The assessment must compare device performance with a
clinical comparator device (e.g., polysomnography).
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) The performance data must be provided to demonstrate the
electromagnetic compatibility and electrical, mechanical, and thermal
safety of the device.
(4) A software description and the results of verification and
validation testing based on a comprehensive hazard analysis and risk
assessment must include:
(i) A full characterization of the software technical parameters,
including algorithms;
(ii) A description of the expected impact of all applicable sensor
acquisition hardware characteristics and associated hardware
specifications; and
(iii) A description of all mitigations for failure of any subsystem
components (including signal detection, signal analysis, data display,
and storage) on output accuracy.
(5) Labeling must include:
(i) A description of what the device measures and outputs to the
user;
(ii) Warnings identifying sensor acquisition factors or subject
conditions or characteristics (e.g., conditions affecting the anatomy
of the recording site, or subject conditions that may affect mandibular
movement) that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a
statement that the device is not intended as a substitute for full
polysomnography nor intended to be used as an apnea monitor; and
(iv) The expected performance of the device for all intended use
populations and environments.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07862 Filed 4-21-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 22, 2026.
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