[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3634-3636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01048]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2022-N-3255]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Computerized Behavioral Therapy Device for Treating Symptoms of 
Gastrointestinal Conditions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the computerized behavioral therapy device for treating 
symptoms of gastrointestinal 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 computerized behavioral therapy device for treating symptoms of 
gastrointestinal 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 20, 2023. The classification was 
applicable on November 25, 2020.

FOR FURTHER INFORMATION CONTACT: Stephanie Cole, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002, 301-796-8587, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the computerized behavioral 
therapy device for treating symptoms of gastrointestinal 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).

[[Page 3635]]

    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 April 30, 2020, FDA received Mahana Therapeutics, Inc.'s request 
for De Novo classification of the Parallel. 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 November 25, 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 
876.5960.\1\ We have named the generic type of device computerized 
behavioral therapy device for treating symptoms of gastrointestinal 
conditions, and it is identified as a prescription device intended to 
provide a computerized version of condition-specific therapy as an 
adjunct to standard of care treatments to patients with 
gastrointestinal conditions.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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--Computerized Behavioral Therapy Device for Treating Symptoms of
        Gastrointestinal Conditions Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Worsening of condition due to device     Clinical data, and Labeling.
 providing ineffective treatment.
Delayed access to treatment due to       Software verification,
 device software failure.                 validation, and hazard
                                          analysis, and Labeling.
Ineffective treatment due to use error/  Usability assessment, and
 improper use of device.                  Labeling.
Treatment results in anxiety, depressed  Clinical data, and Labeling.
 mood, depression, mental disorder
 (unspecified), stress or suicidal
 ideation.
------------------------------------------------------------------------

    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, computerized behavioral therapy 
devices for treating symptoms of gastrointestinal 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 876

    Medical devices.


[[Page 3636]]


    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

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


0
2. Add Sec.  876.5960 to subpart F to read as follows:


Sec.  876.5960   Computerized behavioral therapy device for treating 
symptoms of gastrointestinal conditions.

    (a) Identification. A computerized behavioral therapy device for 
treating symptoms of gastrointestinal conditions is a prescription 
device intended to provide a computerized version of condition-specific 
therapy as an adjunct to standard of care treatments to patients with 
gastrointestinal conditions.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must be provided to fulfill the following:
    (i) Describe a model of therapy for the indicated gastrointestinal 
conditions;
    (ii) Validate the model of therapy as implemented by the device 
using a clinically defined endpoint; and
    (iii) Evaluate all adverse events.
    (2) Software must be described in detail in the software 
requirements specification and software design specification. Software 
verification, validation, and hazard analysis must be performed. 
Software documentation must demonstrate that the device effectively 
implements the behavioral therapy model.
    (3) Usability assessment must demonstrate that the intended user(s) 
can safely and correctly use the device.
    (4) Labeling:
    (i) 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 requirements that support the software of the device;
    (iii) Patient and physician labeling must include a warning that 
the device is not intended for use in lieu of a standard therapeutic 
intervention or to represent a substitution for the patient's 
medication;
    (iv) Patient and physician labeling must include a warning to seek 
medical care if a patient has feelings or thoughts of harming 
themselves or others; and
    (v) Physician and patient labeling must include a summary of the 
clinical testing with the device.

    Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01048 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P


