[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 [www.gpo.gov]
[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, 
[email protected].

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.
 Failure to seek treatment
 despite acute symptoms.
 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