[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Rules and Regulations]
[Pages 71155-71156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2024-N-3992]


Medical Devices; Neurological Devices; Classification of the 
Digital Therapy Device for Attention Deficit Hyperactivity Disorder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the digital therapy device for Attention Deficit Hyperactivity Disorder 
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 for Attention Deficit 
Hyperactivity Disorder'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 September 3, 2024. The classification 
was applicable on June 15, 2020.

FOR FURTHER INFORMATION CONTACT: Tushar Bansal, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4104, Silver Spring, MD 20993-0002, 240-402-4684, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the digital therapy device for 
Attention Deficit Hyperactivity Disorder as class II (special 
controls), which we have determined will provide a reasonable assurance 
of safety and effectiveness.
    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 (see also part 860, subpart D (21 CFR part 860, subpart D)). 
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 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 
510(k) process, when necessary, to market their device.

II. De Novo Classification

    On April 16, 2020, FDA received Akili Interactive Labs Inc.'s 
request for De Novo classification of the EndeavorRx device. 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 June 15, 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 
882.5803.\1\ We have named the generic type of device digital therapy 
device for Attention Deficit Hyperactivity Disorder (ADHD), and it is 
identified as software intended to provide therapy for ADHD or any of 
its individual symptoms as an adjunct to clinician supervised 
treatment.
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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

[[Page 71156]]

this type of device and the measures required to mitigate these risks 
in table 1.

   Table 1--Digital Therapy Device for Attention Deficit Hyperactivity
                 Disorder Risks and Mitigation Measures
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         Identified risks to health              Mitigation measures
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Ineffective treatment leading to worsening   Clinical performance
 or uncontrolled symptoms.                    testing, and Labeling.
Device software failure leading to delayed   Software verification and
 access.                                      validation, and Labeling.
Treatment results in frustration, emotional  Labeling; Clinical
 reaction, dizziness, nausea, headache, eye-  performance testing; and
 strain, or joint pain.                       Software verification,
                                              validation, and hazard
                                              analysis.
Treatment results in seizure...............  Labeling, and Clinical
                                              performance testing.
Treatment results in screen addiction......  Labeling, and Clinical
                                              performance testing.
Treatment results in decreased sleep         Labeling, and Clinical
 quality.                                     performance testing.
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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 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 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.  882.5803 to read as follows:


Sec.  882.5803   Digital therapy device for Attention Deficit 
Hyperactivity Disorder.

    (a) Identification. A digital therapy device for Attention Deficit 
Hyperactivity Disorder (ADHD) is a software intended to provide therapy 
for ADHD or any of its individual symptoms as an adjunct to clinician 
supervised treatment.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate and document the 
following under the labeled conditions for use, which include 
considerations for the ability of the device to:
    (i) Use a validated measure to evaluate effectiveness of device to 
provide therapy for ADHD or any of its individual symptoms; and
    (ii) Capture all adverse events.
    (2) Software must be described and provided in a clear and detailed 
manner to include all features and functions of the software 
implementing the digital therapy. Software verification, validation, 
and hazard analysis must also be provided.
    (3) The labeling must include the following items:
    (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 (OS) 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 standalone 
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: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19720 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-P