Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use 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 infant pulse rate and oxygen saturation monitor for over-the-counter use. 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 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Rules and Regulations]
[Pages 64615-64617]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2026-N-10993]


Medical Devices; Cardiovascular Devices; Classification of the 
Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter 
Use

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 
infant pulse rate and oxygen saturation monitor for over-the-counter 
use 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 infant pulse rate and 
oxygen saturation monitor for over-the-counter use. 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 9, 2026. The classification was 
applicable on November 8, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Crowley, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2272, Silver Spring, MD 20993-0002, 301-
796-6017, <a href="/cdn-cgi/l/email-protection#642f0d09060116081d4a27160b1308011d240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="eba08286898e998792c5a899849c878e92ab8d8f8ac5838398c58c849d">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the infant 
pulse rate and oxygen saturation monitor for over-the-counter use 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 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 December 14, 2022, FDA received Owlet Baby Care, Inc.'s request 
for De Novo classification of the Dream Sock 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

[[Page 64616]]

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 November 8, 2023, 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 
870.2705.\1\ We have named the generic type of device ``infant pulse 
rate and oxygen saturation monitor for over-the-counter use,'' and it 
is identified as a device that uses photoplethysmography to measure 
pulse rate and oxygen saturation in infants. The device may contain 
alarms that alert the caregiver when vital sign(s) go outside preset 
threshold(s).
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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 Infant Pulse Rate
         and Oxygen Saturation Monitors for Over-the-Counter Use
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       Identified risks to health              Mitigation measures
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Poor quality incoming                    Clinical performance testing;
 photoplethysmography signal resulting    Human factors testing;
 in failure to detect pulse rate and      Electrical safety testing;
 oxygen saturation.                       Electromagnetic compatibility
                                          testing; and Labeling.
Misinterpretation and/or over-reliance   Human factors testing; and
 on device output, leading to failure     Labeling.
 to seek treatment despite acute
 symptoms.
Adverse tissue reaction................  Clinical performance testing;
                                          Biocompatibility evaluation;
                                          Human factors testing; and
                                          Labeling.
False positive leading to unnecessary    Clinical performance testing;
 medical procedures.                      Non-clinical performance
                                          testing; Software
                                          verification, validation, and
                                          hazard analysis; Human factors
                                          testing; and Labeling.
False negative resulting in failure to   Clinical performance testing;
 detect high or low pulse rate event      Non-clinical performance
 and/or low SpO2 level event.             testing; Software
                                          verification, validation, and
                                          hazard analysis; Human factors
                                          testing; and Labeling.
------------------------------------------------------------------------

    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 infant pulse rate and 
oxygen saturation monitors for over-the-counter use. 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 870

    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 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  870.2705 to subpart C to read as follows:


Sec.  870.2705   Infant pulse rate and oxygen saturation monitor for 
over-the-counter use.

    (a) Identification. An infant pulse rate and oxygen saturation 
monitor for over-the-counter use is a device that uses 
photoplethysmography to measure pulse rate and oxygen saturation in 
infants. The device may contain alarms that alert the caregiver when 
vital sign(s) go outside preset threshold(s).

[[Page 64617]]

    (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. Testing must 
include the following:
    (i) Evaluation of the effect of confounding variables, like skin 
pigmentation, on performance;
    (ii) Demonstration of the consistency of the output and 
representativeness of the range of data sources and data quality likely 
to be encountered in the intended use population and relevant use 
conditions in the intended use environment; and
    (iii) Evaluation of all adverse events, including skin irritation.
    (2) Software verification, validation, and hazard analysis must be 
performed. Documentation must include:
    (i) Technical specifications of the software, including software 
algorithm(s) and its inputs and outputs; and
    (ii) Specification of acceptable incoming sensor data quality 
control measures.
    (3) Non-clinical performance testing must demonstrate the ability 
of the device to detect adequate photoplethysmography signal quality 
and validate any alarms.
    (4) The skin-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Performance testing must support the electrical safety and 
electromagnetic compatibility of the electrical components of the 
device.
    (6) Human factors and usability testing must demonstrate the 
following:
    (i) The caregiver can correctly use the device based solely on 
reading the device labeling; and
    (ii) The caregiver can correctly interpret the device outputs and 
understand next steps to take based on the outputs.
    (7) Labeling must include:
    (i) Instructions for identifying the intended use population of the 
device, including populations where the device should not be used, and 
conditions of monitoring;
    (ii) A description of what the device measures and outputs to the 
caregiver, including instructions for the interpretation of results and 
appropriate actions;
    (iii) Situations in which the device may not operate at an expected 
performance level; and
    (iv) Instructions for cleaning the device and cleaning frequency.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20726 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P


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