Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea 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 over-the-counter device to assess risk of sleep apnea. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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 209 (Friday, October 30, 2026)</title>
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[Federal Register Volume 91, Number 209 (Friday, October 30, 2026)]
[Rules and Regulations]
[Pages 68462-68465]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2026-N-12385]


Medical Devices; Anesthesiology Devices; Classification of the 
Over-the-Counter Device To Assess Risk of Sleep Apnea

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 
over-the-counter device to assess risk of sleep apnea 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 over-the-counter device to assess risk of 
sleep apnea. We are taking this action because we have determined that 
classifying the device into class II will provide a reasonable 
assurance of the 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 October 30, 2026. The classification was 
applicable on February 6, 2024.

FOR FURTHER INFORMATION CONTACT: Prakhyat Singh, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1255, Silver Spring, MD 20993-0002, 301-796-6562, 
<a href="/cdn-cgi/l/email-protection#afffddcec4c7d6cedb81fcc6c1c8c7efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="cc9cbeada7a4b5adb8e29fa5a2aba48caaa8ade2a4a4bfe2aba3ba">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the over-the-
counter device to assess risk of sleep apnea into class II (special 
controls), which we have determined will provide a reasonable assurance 
of the 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

[[Page 68463]]

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 May 31, 2023, FDA received Samsung Electronics Co., Ltd's 
request for De Novo classification of the Sleep Apnea Feature. 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 the 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 February 6, 2024, 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 
868.2378.\1\ We have named the generic type of device ``over-the-
counter device to assess risk of sleep apnea,'' and it is identified as 
a device that is intended to provide a notification of the risk of 
sleep apnea in users who have not been previously diagnosed with sleep 
apnea. This device uses software algorithms to analyze input sensor 
signals and provide a risk assessment for sleep apnea. It is not 
intended to provide a standalone diagnosis, replace traditional methods 
of diagnosis (e.g., polysomnography), assist clinicians in diagnosing 
sleep disorders, or 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 Over-the-Counter
                  Devices To Assess Risk of Sleep Apnea
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       Identified risks to health              Mitigation measures
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False negative resulting in failure to   Clinical performance testing;
 assess risk of sleep apnea and delay     Non-clinical performance
 of further evaluation or treatment.      testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
False positive resulting in additional   Clinical performance testing;
 unnecessary medical procedures.          Non-clinical performance
                                          testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Misinterpretation and/or overreliance
 on device output, leading to:
    <bullet> Failure to seek treatment
     despite sleep apnea symptoms.
    <bullet> Discontinuing or modifying  Human factors testing; and
     treatment for sleep apnea.           Labeling.
Poor quality sensor data input to the    Non-clinical performance
 device software function resulting in    testing Software verification,
 incorrect sleep apnea assessment.        validation, and hazard
                                          analysis; and Human factors
                                          testing Labeling.
Electrical shock, burn, or interference  Electrical safety testing;
 with other devices (for device           Electromagnetic compatibility
 hardware components).                    testing; and Labeling.

[[Page 68464]]

 
Adverse tissue reaction (for device      Biocompatibility evaluation.
 hardware components).
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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 the 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 over-the-counter devices 
to assess risk of sleep apnea. This device is therefore subject to 
premarket notification requirements under section 510(k) of the FD&C 
Act.

III. Analysis of Environmental Impact

    We have 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.  868.2378 to subpart C to read as follows:


Sec.  868.2378  Over-the-counter device to assess risk of sleep apnea.

    (a) Identification. An over-the-counter device to assess risk of 
sleep apnea is intended to provide a notification of the risk of sleep 
apnea in users who have not been previously diagnosed with sleep apnea. 
This device uses software algorithms to analyze input sensor signals 
and provide a risk assessment for sleep apnea. It is not intended to 
provide a standalone diagnosis, replace traditional methods of 
diagnosis (e.g., polysomnography), assist clinicians in diagnosing 
sleep disorders, or be used as an apnea monitor.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. This testing 
must fulfill the following:
    (i) Testing must include a study population representative of the 
intended use population for the device, including subjects symptomatic 
and asymptomatic of sleep apnea. 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 evaluate device performance across all 
applicable subgroups (e.g., age, sex, body mass index, skin tone).
    (iv) The assessment must compare device performance with a clinical 
comparator device (e.g., polysomnography) to demonstrate the required 
accuracy and/or sensitivity and specificity of the output measure(s). 
Justification for the clinical comparator as ground truth must be 
provided.
    (v) For devices with machine learning-based algorithms, the 
clinical validation must be completed using a dataset that is separate 
from the training dataset.
    (2) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. Performance 
testing must demonstrate hardware compatibility and the ability of the 
device software and hardware to provide adequate input signal quality 
and handle noisy or missing data and poor signal quality.
    (3) Performance data must be provided to demonstrate the 
electromagnetic compatibility and electrical, mechanical, and thermal 
safety of any device hardware components.
    (4) Any device hardware components that are skin-contacting must be 
demonstrated to be biocompatible.
    (5) Software verification, validation, and hazard analysis must be 
performed. Software documentation must include:
    (i) Full characterization of the technical specifications of the 
software, including the detection algorithm and its inputs and outputs.
    (ii) A description of the expected impact of all applicable sensor 
acquisition hardware characteristics, associated hardware 
specifications, and processing software; 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.
    (6) Human factors and usability testing must demonstrate the 
following:
    (i) The user can correctly use the device based solely on reading 
the directions for use; and
    (ii) The user can correctly interpret the device output and 
understand when to seek medical care.

[[Page 68465]]

    (7) Labeling must include:
    (i) A description of what the device measures and outputs to the 
user;
    (ii) Hardware platform and operating system requirements;
    (iii) The type of sensor data used, including specifications of 
compatible hardware used for data acquisition;
    (iv) Warnings identifying sensor acquisition factors or subject 
conditions or characteristics that may impact measurement results;
    (v) Information for interpretation of the measurements, including a 
statement that the device is not intended to replace traditional 
methods of diagnosis (e.g., polysomnography) nor intended to be used as 
an apnea monitor;
    (vi) A summary of the clinical performance testing with the device, 
including both the device's overall performance as well as performance 
across all relevant subgroups.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22182 Filed 10-29-26; 8:45 am]
BILLING CODE 4164-01-P


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