Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders, 61166-61168 [2017-27843]
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61166
Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
including limit of blank, limit of
detection, and limit of quantification.
(iv) Identification of risk mitigation
elements used by the device, including
a detailed description of all additional
procedures, methods, and practices
incorporated into the instructions for
use that mitigate risks associated with
testing the device.
(2) The 21 CFR 809.10 compliant
labeling must include the following:
(i) The intended use statement in the
21 CFR 809.10(a)(2) and (b)(2)
compliant labeling must include a
statement that the results should be
interpreted by a pathologist or
equivalent professional in conjunction
with other clinical and laboratory
findings. The intended use statement
must also include information on what
the device detects and measures,
whether the device is qualitative, semiquantitative, and/or quantitative, the
clinical indications for which the device
is to be used, and the specific
population(s) for which the device is
intended.
(ii) A detailed description of the
performance studies conducted to
comply with paragraph (b)(1)(iii) of this
section and a summary of the results.
(3) As part of the risk management
activities performed under 21 CFR
820.30 design controls, product labeling
and instruction manuals must include
clear examples of all expected
phenotypic patterns and gating
strategies using well-defined clinical
samples representative of both abnormal
and normal cellular populations. These
samples must be selected based upon
the indications described in paragraph
(b)(1)(i) of this section.
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27855 Filed 12–26–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
daltland on DSKBBV9HB2PROD with RULES
[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.
The Food and Drug
Administration (FDA or we) is
SUMMARY:
VerDate Sep<11>2014
18:49 Dec 26, 2017
Jkt 244001
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,
Patrick.Antkowiak@fda.hhs.gov.
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.
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\27DER1.SGM
27DER1
Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
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
61167
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, leading to worsening condition ...
Clinical data; Software verification, validation, and hazard analysis; and
labeling.
Software verification, validation, and hazard analysis; and Labeling.
Labeling.
Device software failure, leading to delayed access .................................
Use error/improper device use .................................................................
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.
III. Analysis of Environmental Impact
daltland on DSKBBV9HB2PROD with RULES
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)).
List of Subjects in 21 CFR Part 882
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.
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:
IV. Paperwork Reduction Act of 1995
PART 882—NEUROLOGICAL DEVICES
This final order establishes special
controls that refer to previously
VerDate Sep<11>2014
18:49 Dec 26, 2017
Jkt 244001
1. The authority citation for part 882
continues to read as follows:
■
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 882.5801 to subpart F to read
as follows:
■
§ 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 conditionspecific 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.
E:\FR\FM\27DER1.SGM
27DER1
61168
Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
(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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2017–N–6531]
Medical Devices; Neurological
Devices; Classification of the External
Vagal Nerve Stimulator for Headache
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the external vagal nerve
stimulator for headache 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 external
vagal nerve stimulator for headache’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,
in part by reducing regulatory burdens.
DATES: This order is effective December
27, 2017. The classification was
applicable on April 14, 2017.
FOR FURTHER INFORMATION CONTACT:
William Heetderks, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2682, Silver Spring,
daltland on DSKBBV9HB2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
18:49 Dec 26, 2017
Jkt 244001
MD 20993–0002, 240–402–5360,
William.Heetderks@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
external vagal nerve stimulator for
headache 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 (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 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
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
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.
II. De Novo Classification
On October 16, 2015, electroCore,
LLC, submitted a request for De Novo
classification of the gammaCore Noninvasive Vagus Nerve Stimulator. 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.
E:\FR\FM\27DER1.SGM
27DER1
]]>Agencies
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61166-61168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27843]
-----------------------------------------------------------------------
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
