82 FR 61166 - Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

Page Range		61166-61168
FR Document		2017-27843

The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders 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 psychiatric disorders' 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, in part by reducing regulatory burdens.

Federal Register, Volume 82 Issue 247 (Wednesday, December 27, 2017)

[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61166-61168]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-6642]


Medical Devices; Neurological Devices; Classification of the 
Computerized Behavioral Therapy Device for Psychiatric Disorders

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the computerized behavioral therapy device for psychiatric disorders 
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 
psychiatric disorders' 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, in part by reducing 
regulatory burdens.

DATES: This order is effective December 27, 2017. The classification 
was applicable on September 14, 2017.

FOR FURTHER INFORMATION CONTACT: Patrick Antkowiak, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2663, Silver Spring, MD 20993-0002, 240-
402-3705, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the computerized behavioral 
therapy device for psychiatric disorders 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 reducing 
regulatory burdens 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 (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 by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall 
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, in part by reducing regulatory 
burdens. 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 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

[[Page 61167]]

II. De Novo Classification

    On May 16, 2016, Pear Therapeutics, Inc., submitted a request for 
De Novo classification of the reSET. 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 14, 2017, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 882.5801. We have named 
the generic type of device computerized behavioral therapy device for 
psychiatric disorders, and it is identified as a prescription only 
device intended to provide a computerized version of condition-specific 
behavioral therapy as an adjunct to clinician supervised outpatient 
treatment to patients with psychiatric conditions. The digital therapy 
is intended to provide patients access to therapy tools used during 
treatment sessions to improve recognized treatment outcomes.
    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 Psychiatric
                 Disorders Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Device provides ineffective treatment,   Clinical data; Software
 leading to worsening condition.          verification, validation, and
                                          hazard analysis; and labeling.
Device software failure, leading to      Software verification,
 delayed access.                          validation, and hazard
                                          analysis; and Labeling.
Use error/improper device use..........  Labeling.
------------------------------------------------------------------------

    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 psychiatric disorders 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 (referring to 21 U.S.C. 
352(f)(1)).

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. 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. 3501-3520). 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; 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, Neurological 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.  882.5801 to subpart F to read as follows:


Sec.  882.5801   Computerized behavioral therapy device for psychiatric 
disorders.

    (a) Identification. A computerized behavioral therapy device for 
psychiatric disorders is a prescription only device intended to provide 
a computerized version of condition-specific behavioral therapy as an 
adjunct to clinician supervised outpatient treatment to patients with 
psychiatric conditions. The digital therapy is intended to provide 
patients access to therapy tools used during treatment sessions to 
improve recognized treatment outcomes.
    (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 validated model of behavioral therapy for the 
psychiatric disorder; and
    (ii) Validate the model of behavioral therapy as implemented by the 
device.
    (2) Software must be described in detail in the software 
requirements specification (SRS) and software design specification 
(SDS). Software verification, validation, and hazard analysis must be 
performed. Software documentation must demonstrate that the device 
effectively implements the behavioral therapy model.

[[Page 61168]]

    (3) The following labeling must be provided:
    (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 compatible devices.
    (iii) Patient and physician labeling must include a warning that 
the device is not intended for use as a standalone therapy.
    (iv) Patient and physician labeling must include a warning that the 
device does not represent a substitution for the patient's medication.
    (v) Physician labeling must include a summary of the clinical 
testing with the device.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27843 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 61167

II. De Novo Classification its intended use (see 21 U.S.C. for psychiatric disorders, and it is
360c(a)(1)(B)). After review of the identified as a prescription only device
On May 16, 2016, Pear Therapeutics, information submitted in the request, intended to provide a computerized
Inc., submitted a request for De Novo we determined that the device can be version of condition-specific behavioral
classification of the reSET. FDA classified into class II with the therapy as an adjunct to clinician
reviewed the request in order to classify establishment of special controls. FDA
the device under the criteria for supervised outpatient treatment to
has determined that these special patients with psychiatric conditions.
classification set forth in section controls, in addition to the general
513(a)(1) of the FD&C Act. The digital therapy is intended to
controls, will provide reasonable provide patients access to therapy tools
We classify devices into class II if assurance of the safety and effectiveness used during treatment sessions to
general controls by themselves are of the device.
improve recognized treatment
insufficient to provide reasonable Therefore, on September 14, 2017,
assurance of safety and effectiveness, FDA issued an order to the requester outcomes.
but there is sufficient information to classifying the device into class II. FDA FDA has identified the following risks
establish special controls that, in is codifying the classification of the to health associated specifically with
combination with the general controls, device by adding 21 CFR 882.5801. We this type of device and the measures
provide reasonable assurance of the have named the generic type of device required to mitigate these risks in table
safety and effectiveness of the device for computerized behavioral therapy device 1.

TABLE 1—COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR PSYCHIATRIC DISORDERS RISKS AND MITIGATION
MEASURES
Identified risks Mitigation measures

Device provides ineffective treatment, leading to worsening condition ... Clinical data; Software verification, validation, and hazard analysis; and
labeling.
Device software failure, leading to delayed access ................................. Software verification, validation, and hazard analysis; and Labeling.
Use error/improper device use ................................................................. Labeling.

FDA has determined that special approved collections of information Authority: 21 U.S.C. 351, 360, 360c, 360e,
controls, in combination with the found in other FDA regulations. These 360j, 360l, 371.
general controls, address these risks to collections of information are subject to ■ 2. Add § 882.5801 to subpart F to read
health and provide reasonable assurance review by the Office of Management and as follows:
of safety and effectiveness. For a device Budget (OMB) under the Paperwork
to fall within this classification, and Reduction Act of 1995 (44 U.S.C. 3501– § 882.5801 Computerized behavioral
therapy device for psychiatric disorders.
thus avoid automatic classification in 3520). The collections of information in
class III, it would have to comply with the guidance document ‘‘De Novo (a) Identification. A computerized
the special controls named in this final Classification Process (Evaluation of behavioral therapy device for
order. The necessary special controls Automatic Class III Designation)’’ have psychiatric disorders is a prescription
appear in the regulation codified by this been approved under OMB control only device intended to provide a
order. This device is subject to number 0910–0844; the collections of computerized version of condition-
premarket notification requirements information in 21 CFR part 814, specific behavioral therapy as an
under section 510(k) of the FD&C Act. subparts A through E, regarding adjunct to clinician supervised
At the time of classification, premarket approval, have been outpatient treatment to patients with
computerized behavioral therapy approved under OMB control number psychiatric conditions. The digital
devices for psychiatric disorders are for 0910–0231; the collections of therapy is intended to provide patients
prescription use only. Prescription information in part 807, subpart E, access to therapy tools used during
devices are exempt from the regarding premarket notification treatment sessions to improve
requirement for adequate directions for submissions, have been approved under recognized treatment outcomes.
use for the layperson under section OMB control number 0910–0120; and (b) Classification. Class II (special
502(f)(1) of the FD&C Act (21 U.S.C. the collections of information in 21 CFR controls). The special controls for this
352(f)(1)) and 21 CFR 801.5, as long as part 801, regarding labeling, have been device are:
the conditions of 21 CFR 801.109 are approved under OMB control number (1) Clinical data must be provided to
met (referring to 21 U.S.C. 352(f)(1)). 0910–0485. fulfill the following:
(i) Describe a validated model of
III. Analysis of Environmental Impact List of Subjects in 21 CFR Part 882 behavioral therapy for the psychiatric
The Agency has determined under 21 Medical devices, Neurological disorder; and
CFR 25.34(b) that this action is of a type devices. (ii) Validate the model of behavioral
that does not individually or Therefore, under the Federal Food, therapy as implemented by the device.
cumulatively have a significant effect on Drug, and Cosmetic Act and under (2) Software must be described in
the human environment. Therefore, authority delegated to the Commissioner detail in the software requirements
specification (SRS) and software design
daltland on DSKBBV9HB2PROD with RULES

neither an environmental assessment of Food and Drugs, 21 CFR part 882 is
nor an environmental impact statement amended as follows: specification (SDS). Software
is required. verification, validation, and hazard
PART 882—NEUROLOGICAL DEVICES analysis must be performed. Software
IV. Paperwork Reduction Act of 1995 documentation must demonstrate that
This final order establishes special ■ 1. The authority citation for part 882 the device effectively implements the
controls that refer to previously continues to read as follows: behavioral therapy model.

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61168 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations

(3) The following labeling must be MD 20993–0002, 240–402–5360, then requests a classification under
provided: William.Heetderks@fda.hhs.gov. section 513(f)(2).
(i) Patient and physician labeling SUPPLEMENTARY INFORMATION: Under the second procedure, rather
must include instructions for use, than first submitting a 510(k) and then
including images that demonstrate how I. Background
a request for classification, if the person
to interact with the device. Upon request, FDA has classified the determines that there is no legally
(ii) Patient and physician labeling external vagal nerve stimulator for marketed device upon which to base a
must list compatible devices. headache as class II (special controls), determination of substantial
(iii) Patient and physician labeling which we have determined will provide equivalence, that person requests a
must include a warning that the device a reasonable assurance of safety and classification under section 513(f)(2) of
is not intended for use as a standalone effectiveness. In addition, we believe the FD&C Act.
therapy. this action will enhance patients’ access Under either procedure for De Novo
(iv) Patient and physician labeling to beneficial innovation, in part by classification, FDA shall classify the
must include a warning that the device reducing regulatory burdens by placing device by written order within 120 days.
does not represent a substitution for the the device into a lower device class than The classification will be according to
patient’s medication. the automatic class III assignment. the criteria under section 513(a)(1) of
(v) Physician labeling must include a The automatic assignment of class III the FD&C Act. Although the device was
summary of the clinical testing with the occurs by operation of law and without automatically placed within class III,
device. any action by FDA, regardless of the the De Novo classification is considered
level of risk posed by the new device. to be the initial classification of the
Dated: December 20, 2017.
Any device that was not in commercial device.
Leslie Kux,
distribution before May 28, 1976, is
Associate Commissioner for Policy. We believe this De Novo classification
automatically classified as, and remains
[FR Doc. 2017–27843 Filed 12–26–17; 8:45 am] will enhance patients’ access to
within, class III and requires premarket
beneficial innovation, in part by
BILLING CODE 4164–01–P approval unless and until FDA takes an
reducing regulatory burdens. When FDA
action to classify or reclassify the device
classifies a device into class I or II via
(see 21 U.S.C. 360c(f)(1)). We refer to
DEPARTMENT OF HEALTH AND these devices as ‘‘postamendments the De Novo process, the device can
HUMAN SERVICES devices’’ because they were not in serve as a predicate for future devices of
commercial distribution prior to the that type, including for 510(k)s (see 21
Food and Drug Administration date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
Amendments of 1976, which amended device sponsors do not have to submit
21 CFR Part 882 the Federal Food, Drug, and Cosmetic a De Novo request or premarket
[Docket No. FDA–2017–N–6531] Act (FD&C Act). approval application in order to market
FDA may take a variety of actions in a substantially equivalent device (see 21
Medical Devices; Neurological appropriate circumstances to classify or U.S.C. 360c(i), defining ‘‘substantial
Devices; Classification of the External reclassify a device into class I or II. We equivalence’’). Instead, sponsors can use
Vagal Nerve Stimulator for Headache may issue an order finding a new device the less-burdensome 510(k) process,
to be substantially equivalent under when necessary, to market their device.
AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act (21
HHS. II. De Novo Classification
U.S.C. 360c(i)) to a predicate device that
ACTION: Final order. does not require premarket approval. On October 16, 2015, electroCore,
We determine whether a new device is LLC, submitted a request for De Novo
SUMMARY: The Food and Drug classification of the gammaCore Non-
substantially equivalent to a predicate
Administration (FDA or we) is invasive Vagus Nerve Stimulator. FDA
by means of the procedures for
classifying the external vagal nerve reviewed the request in order to classify
premarket notification under section
stimulator for headache into class II the device under the criteria for
510(k) of the FD&C Act (21 U.S.C.
(special controls). The special controls classification set forth in section
360(k)) and part 807 (21 CFR part 807).
that apply to the device type are FDA may also classify a device 513(a)(1) of the FD&C Act.
identified in this order and will be part through ‘‘De Novo’’ classification, a We classify devices into class II if
of the codified language for the external common name for the process general controls by themselves are
vagal nerve stimulator for headache’s authorized under section 513(f)(2) of the insufficient to provide reasonable
classification. We are taking this action FD&C Act. Section 207 of the Food and assurance of safety and effectiveness,
because we have determined that Drug Administration Modernization Act but there is sufficient information to
classifying the device into class II of 1997 established the first procedure establish special controls that, in
(special controls) will provide a for De Novo classification (Pub. L. 105– combination with the general controls,
reasonable assurance of safety and 115). Section 607 of the Food and Drug provide reasonable assurance of the
effectiveness of the device. We believe Administration Safety and Innovation safety and effectiveness of the device for
this action will also enhance patients’ Act modified the De Novo application its intended use (see 21 U.S.C.
access to beneficial innovative devices, process by adding a second procedure 360c(a)(1)(B)). After review of the
in part by reducing regulatory burdens. (Pub. L. 112–144). A device sponsor information submitted in the request,
DATES: This order is effective December may utilize either procedure for De we determined that the device can be
27, 2017. The classification was classified into class II with the
daltland on DSKBBV9HB2PROD with RULES

Novo classification.
applicable on April 14, 2017. Under the first procedure, the person establishment of special controls. FDA
FOR FURTHER INFORMATION CONTACT: submits a 510(k) for a device that has has determined that these special
William Heetderks, Center for Devices not previously been classified. After controls, in addition to the general
and Radiological Health, Food and Drug receiving an order from FDA classifying controls, will provide reasonable
Administration, 10903 New Hampshire the device into class III under section assurance of the safety and effectiveness
Ave., Bldg. 66, Rm. 2682, Silver Spring, 513(f)(1) of the FD&C Act, the person of the device.

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Document Created: 2017-12-27 02:22:45
Document Modified: 2017-12-27 02:22:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective December 27, 2017. The classification was applicable on September 14, 2017.
Contact		Patrick Antkowiak, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2663, Silver Spring, MD 20993-0002, 240- 402-3705, [email protected]
FR Citation		82 FR 61166
CFR Associated		Medical Devices and Neurological Devices

82 FR 61166 - Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration