[Federal Register Volume 88, Number 9 (Friday, January 13, 2023)]
[Rules and Regulations]
[Pages 2222-2224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00497]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2022-N-3240]


Medical Devices; Neurological Devices; Classification of the 
Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric 
Conditions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the digital therapy device to reduce sleep disturbance for 
psychiatric conditions 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 digital therapy device to 
reduce sleep disturbance for psychiatric conditions' 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 13, 2023. The classification was 
applicable on November 6, 2020.

FOR FURTHER INFORMATION CONTACT: Patrick Antkowiak, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4118, Silver Spring, MD 20993-0002, 240-
402-3705, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the digital therapy device to 
reduce sleep disturbance for psychiatric conditions 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 May 27, 2020, FDA received NightWare, Inc's request for De Novo 
classification of the NightWare Kit (Apple iPhone, Apple Watch, Apple 
iPhone Charging Cable, Apple Watch Charging Cable). 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,

[[Page 2223]]

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 November 6, 2020, 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 
882.5705.\1\ We have named the generic type of device digital therapy 
device to reduce sleep disturbance for psychiatric conditions, and it 
is identified as a prescription device that is intended to provide 
stimulation using a general purpose computing platform to reduce sleep 
disturbance in patients who experience this symptom due to psychiatric 
conditions such as nightmare disorder or post-traumatic stress 
disorder.
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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--Digital Therapy Device To Reduce Sleep Disturbance for
          Psychiatric Conditions Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Ineffective treatment leading to         Clinical performance testing.
 worsening sleep.
Ineffective treatment leading to         Clinical performance testing.
 worsening condition-specific symptoms.
Device software failure leading to       Software verification,
 delayed access and treatment.            validation, and hazard
                                          analysis.
Improper device use leading to           Labeling.
 worsening sleep.
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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.
    At the time of classification, digital therapy devices to reduce 
sleep disturbance for psychiatric conditions are for prescription use 
only. Prescription devices are exempt from the requirement for adequate 
directions for use for the layperson under section 502(f)(1) of the 
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the 
conditions of 21 CFR 801.109 are met.

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 parts 801, regarding labeling, have been approved 
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 882

    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 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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


0
2. Add Sec.  882.5705 to subpart F to read as follows:


Sec.  882.5705  Digital therapy device to reduce sleep disturbance for 
psychiatric conditions.

    (a) Identification. A digital therapy device to reduce sleep 
disturbance for psychiatric conditions is a prescription device that is 
intended to provide stimulation using a general purpose computing 
platform to reduce sleep disturbance in patients who experience this 
symptom due to psychiatric conditions such as nightmare disorder or 
post-traumatic stress disorder.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing under the labeled conditions for 
use must evaluate the following:
    (i) The ability of the device to provide therapy for patients with 
sleep disturbance due to psychiatric conditions, using a validated 
measure;
    (ii) Worsening of any condition-specific symptoms using a validated 
measure for assessment of the particular condition; and
    (iii) Increase in symptoms of disturbed sleep or sleepiness using a 
validated measure.
    (2) Software must clearly describe all features and functions of 
the software implementing the digital therapy. Software verification, 
validation, and hazard analysis must also be provided.

[[Page 2224]]

    (3) The labeling must include the following:
    (i) Patient and physician labeling must include instructions for 
use, including images that demonstrate how to interact with the device;
    (ii) Patient and physician labeling must list the minimum operating 
system and general purpose computing requirements that support the 
software of the device;
    (iii) Patient and physician labeling must include a warning that 
the digital therapy device is not intended for use as a stand-alone 
therapeutic device;
    (iv) Patient and physician labeling must include a warning that the 
digital therapy device does not represent a substitution for the 
patient's medication; and
    (v) Physician labeling must include a summary of the clinical 
performance testing conducted with the device.

    Dated: January 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00497 Filed 1-12-23; 8:45 am]
BILLING CODE 4164-01-P


