[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 975-977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-3189]


Medical Devices; Cardiovascular Devices; Classification of the 
Hardware and Software for Optical Camera-Based Measurement of Pulse 
Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the hardware and software for optical camera-based 
measurement of pulse rate, heart rate, breathing rate, and/or 
respiratory rate 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 the hardware and software for optical 
camera-based measurement of pulse rate, heart rate, breathing rate, 
and/or respiratory rate's classification. We are taking this action 
because we have determined that classifying the device into class II 
(special controls) 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.

DATES: This order is effective January 6, 2023. The classification was 
applicable on April 1, 2021.

FOR FURTHER INFORMATION CONTACT: Jennifer Kozen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2272, Silver Spring, MD 20993-0002, 307-796-5813, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the hardware and software for 
optical camera-based measurement of pulse rate, heart rate, breathing 
rate, and/or respiratory rate as class II (special controls), which we 
have determined will provide a reasonable assurance of safety and 
effectiveness. In addition, we believe this action will enhance 
patients' access to beneficial innovation, in part 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 as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 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 (see 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. 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 
application 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 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.
    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 June 12, 2020, FDA received ContinUse Biometrics Ltd.'s request 
for De Novo classification of the Gili Pro BioSensor. 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.

[[Page 976]]

    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, 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 21 U.S.C. 360c(a)(1)(B)). 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 April 1, 2021, 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 
870.2786.\1\ We have named the generic type of device hardware and 
software for optical camera-based measurement of pulse rate, heart 
rate, breathing rate, and/or respiratory rate, and it is identified as 
a device that uses an optical sensor system and software algorithms to 
obtain and analyze video signal and estimate pulse rate, heart rate, 
breathing rate, and/or respiratory rates. This device is not intended 
to independently direct therapy.
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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 following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

 Table 1--Hardware and Software for Optical Camera-Based Measurement of
  Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate Risks
                         and Mitigation Measures
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            Identified risks                   Mitigation measures
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Delayed or incorrect treatment due to    Software verification,
 erroneous output as a result of device   validation, and hazard
 malfunction or algorithm error.          analysis; Cybersecurity
                                          assessment; Clinical data; and
                                          Labeling.
Delayed or incorrect treatment due to    Human factors assessment, and
 user misinterpretation.                  Labeling.
Eye damage, burns, and related safety    Non-clinical performance
 concerns due to illuminating optics.     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 safety and effectiveness. 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 order. This device is 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 individually or cumulatively 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 21 CFR 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 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.  870.2786 to subpart C to read as follows:


Sec.  870.2786  Hardware and software for optical camera-based 
measurement of pulse rate, heart rate, breathing rate, and/or 
respiratory rate.

    (a) Identification. The device uses an optical sensor system and 
software algorithms to obtain and analyze video signal and estimate 
pulse rate, heart rate, breathing rate, and/or respiratory rates. This 
device is not intended to independently direct therapy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) 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 all mitigations for user error or failure of 
any subsystem components (including signal detection, signal analysis, 
data display, and storage) on output accuracy; and
    (iii) Software documentation must include a cybersecurity 
vulnerability and management process to assure software functionality.
    (2) Performance testing must demonstrate the safety of any 
illuminating optics.
    (3) Clinical data must be provided. This assessment must fulfill 
the following:

[[Page 977]]

    (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 output with a clinically 
accurate patient-contacting relevant comparator device in an accurate 
and reproducible manner.
    (4) A human factors and usability engineering assessment must be 
provided that evaluates the risk of improper measurement.
    (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 (garment types/textures, motion, etc.) 
that may impact measurement results;
    (iii) Guidance for interpretation of the measurements, including a 
statement that the output is adjunctive to other physical vital sign 
parameters and patient information;
    (iv) The expected performance of the device for all intended use 
populations and environments; and
    (v) Robust instructions to ensure correct system setup.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00010 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P


