Rule2022-00827
Medical Devices; Cardiovascular Devices; Classification of the Electrocardiograph Software for Over-the-Counter Use
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 18, 2022
Effective
January 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the electrocardiograph software 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 the electrocardiograph software for over-the- counter use'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 87 Issue 11 (Tuesday, January 18, 2022)</title>
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[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Rules and Regulations]
[Pages 2547-2549]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00827]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2021-N-0914]
Medical Devices; Cardiovascular Devices; Classification of the
Electrocardiograph Software for Over-the-Counter Use
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 electrocardiograph software 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 the electrocardiograph software for over-the-
counter use'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 18, 2022. The classification was
applicable on September 11, 2018.
FOR FURTHER INFORMATION CONTACT: Luke Ralston, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2311, Silver Spring, MD 20993-0002, 301-796-6362,
<a href="/cdn-cgi/l/email-protection#5519203e307b07343926213a3b153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="3d71485658136f5c514e4952537d5b595c1355554e135a524b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the electrocardiograph software
for over-the-counter use 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, 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 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). 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
[[Page 2548]]
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. 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 August 14, 2018, FDA received Apple Inc.'s request for De Novo
classification of the ECG App. 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, 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 September 11, 2018, 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
870.2345.\1\ We have named the generic type of device
electrocardiograph software for over-the-counter use, and it is
identified as a device that creates, analyzes, and displays
electrocardiograph data and can provide information for identifying
cardiac arrhythmias. This device is not intended to provide a
diagnosis.
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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--Electrocardiograph Software for Over-the-Counter Use Risks and
Mitigation Measures
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Identified risks Mitigation measures
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Poor quality electrocardiograph (ECG) Clinical performance testing,
signal resulting in failure to detect Human factors testing, and
arrhythmia. Labeling.
Misinterpretation and/or over-reliance Human factors testing, and
on device output, leading to: Labeling.
<bullet> Failure to seek treatment
despite acute symptoms.
<bullet> Discontinuing or modifying
treatment for chronic heart condition.
False negative resulting in failure to Clinical performance testing,
identify arrhythmia and delay of Software verification,
further evaluation or treatment. validation, and hazard
analysis; Non-clinical
performance testing; and
Labeling.
False positive resulting in additional Clinical performance testing;
unnecessary medical procedures. Software verification,
validation, and hazard
analysis; Non-clinical
performance 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' 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:
[[Page 2549]]
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. 870.2345 to subpart C to read as follows:
Sec. 870.2345 Electrocardiograph software for over-the-counter use.
(a) Identification. An electrocardiograph software device for over-
the-counter use creates, analyzes, and displays electrocardiograph data
and can provide information for identifying cardiac arrhythmias. This
device is not intended to provide a diagnosis.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing under anticipated conditions of
use must demonstrate the following:
(i) The ability to obtain an electrocardiograph of sufficient
quality for display and analysis; and
(ii) The performance characteristics of the detection algorithm as
reported by sensitivity and either specificity or positive predictive
value.
(2) Software verification, validation, and hazard analysis must be
performed. Documentation must include a characterization of the
technical specifications of the software, including the detection
algorithm and its inputs and outputs.
(3) Non-clinical performance testing must validate detection
algorithm performance using a previously adjudicated data set.
(4) Human factors and usability testing must demonstrate the
following:
(i) The user can correctly use the device based solely on reading
the device labeling; and
(ii) The user can correctly interpret the device output and
understand when to seek medical care.
(5) Labeling must include:
(i) Hardware platform and operating system requirements;
(ii) Situations in which the device may not operate at an expected
performance level;
(iii) A summary of the clinical performance testing conducted with
the device;
(iv) A description of what the device measures and outputs to the
user; and
(v) Guidance on interpretation of any results.
Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00827 Filed 1-14-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on January 18, 2022.
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