Rule2023-00497
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions
Primary source
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Published
January 13, 2023
Effective
January 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 9 (Friday, January 13, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#4f1f2e3b3d262c24610e213b242038262e240f292b2e6127273c61282039"><span class="__cf_email__" data-cfemail="613100151308020a4f200f150a0e1608000a210705004f0909124f060e17">[email protected]</span></a>.
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
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</html>Indexed from Federal Register on January 13, 2023.
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