Rule2023-00010
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 6, 2023
Effective
January 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 4 (Friday, January 6, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#83c9e6ededeae5e6f1add0ebeaebc3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="450f202b2b2c2320376b162d2c2d052321246b2d2d366b222a33">[email protected]</span></a>.
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.
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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. 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
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</html>Indexed from Federal Register on January 6, 2023.
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