
[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Rules and Regulations]
[Pages 87810-87812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2015-N-2737]


Medical Devices; Neurological Devices; Classification of the 
Computerized Cognitive Assessment Aid for Concussion

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
Computerized Cognitive Assessment Aid for Concussion into class II 
(special controls). The special controls that will apply to the device 
are identified in this order and will be part of the codified language 
for the computerized cognitive assessment aid for concussion's 
classification. The Agency is classifying the device into class II 
(special controls) in order to provide a reasonable assurance of safety 
and effectiveness of the device.

DATES: This order is effective December 6, 2016. The classification was 
applicable on August 22, 2016.

FOR FURTHER INFORMATION CONTACT: Stacie Gutowski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240-
402-6032, Stacie.Gutowski@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as post-amendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act and then a request 
for classification under the first procedure, the person determines 
that there is no legally marketed device upon which to base a 
determination of substantial equivalence and requests a classification 
under section 513(f)(2) of the FD&C Act. If the person submits a 
request to classify the device under this second procedure, FDA may 
decline to undertake the classification request if FDA identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence with the device or if FDA determines 
that the device submitted is not of ``low-moderate risk'' or that 
general controls would be inadequate to control the risks and special 
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On August 11, 2015, ImPACT Applications, Inc., submitted a request 
for classification of the ImPACT and ImPACT Pediatric under section 
513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies 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 to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
request, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on August 22, 2016, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 882.1471.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a 
computerized cognitive assessment aid for concussion will need to 
comply with the special controls named in this final order. The device 
is assigned the generic name computerized cognitive assessment aid for 
concussion, and it is identified as a prescription device that uses an 
individual's score(s) on a battery of cognitive tasks to provide an 
indication of the current level of cognitive function in response to 
concussion. The computerized cognitive assessment aid for concussion is 
used only as an assessment aid in the management of concussion to 
determine cognitive function for patients after a potential concussive 
event where other diagnostic tools are available and does not identify 
the presence or absence of concussion. It is not intended as a stand-
alone diagnostic device.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the mitigation 
measures required to mitigate these risks in table 1.

[[Page 87811]]



 Table 1--Computerized Cognitive Assessment Aid for Concussion Risks and
                           Mitigation Measures
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              Identified risk                    Mitigation measure
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User discomfort (e.g., visual or mental      Labeling.
 fatigue).
Incorrect result, inclusive of:...........   Clinical
 False positive--cognitive           performance testing.
 impairment from concussion when in fact     Software
 none is present.                            verification, validation,
 False negative--cognitive           and hazard analysis.
 impairment from concussion is not noted     Labeling.
 when in fact cognitive impairment is
 present.
------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Computerized cognitive assessment aid for concussion devices are 
not safe for use except under the supervision of a practitioner 
licensed by law to direct the use of the device. As such, the device is 
a prescription device and must satisfy prescription labeling 
requirements (see 21 CFR 801.109 (Prescription devices)).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k), if FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. For this type of device, FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of the device. Therefore, this device type is not 
exempt from premarket notification requirements. Persons who intend to 
market this type of device must submit to FDA a premarket notification, 
prior to marketing the device, which contains information about the 
computerized cognitive assessment aid for concussion they intend to 
market.

II. 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.

III. 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 
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.

    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 is revised to read as follows:

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


0
2. Add Sec.  882.1471 to subpart B to read as follows:


Sec.  882.1471  Computerized cognitive assessment aid for concussion.

    (a) Identification. The computerized cognitive assessment aid for 
concussion is a prescription device that uses an individual's score(s) 
on a battery of cognitive tasks to provide an indication of the current 
level of cognitive function in response to concussion. The computerized 
cognitive assessment aid for concussion is used only as an assessment 
aid in the management of concussion to determine cognitive function for 
patients after a potential concussive event where other diagnostic 
tools are available and does not identify the presence or absence of 
concussion. It is not intended as a stand-alone diagnostic device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software, including any proprietary algorithm(s) used by the 
device to arrive at its interpretation of the patient's cognitive 
function, 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.
    (2) Clinical performance data must be provided that demonstrates 
how the device functions as an interpretation of the current level of 
cognitive function in an individual that has recently received an 
injury that causes concern about a possible concussion. The testing 
must:
    (i) Evaluate device output and clinical interpretation.
    (ii) Evaluate device test-retest reliability of the device output.
    (iii) Evaluate construct validity of the device cognitive 
assessments.
    (iv) Describe the construction of the normative database, which 
includes the following:
    (A) How the clinical workup was completed to establish a ``normal'' 
population, including the establishment of inclusion and exclusion 
criteria.
    (B) Statistical methods and model assumptions used.
    (3) The labeling must include:
    (i) A summary of any clinical testing conducted to demonstrate how 
the device functions as an interpretation of the current level of 
cognitive function in a patient that has recently received an injury 
that causes concern about a possible concussion. The summary of testing 
must include the following:
    (A) Device output and clinical interpretation.
    (B) Device test-retest reliability of the device output.
    (C) Construct validity of the device cognitive assessments.
    (D) A description of the normative database, which includes the 
following:
    (1) How the clinical workup was completed to establish a ``normal'' 
population, including the establishment of inclusion and exclusion 
criteria.
    (2) How normal values will be reported to the user.
    (3) Representative screen shots and reports that will be generated 
to provide the user results and normative data.
    (4) Statistical methods and model assumptions used.
    (5) Whether or not the normative database was adjusted due to 
differences in age and gender.
    (ii) A warning that the device should only be used by health care 
professionals who are trained in concussion management.
    (iii) A warning that the device does not identify the presence or 
absence of concussion or other clinical diagnoses.
    (iv) A warning that the device is not a stand-alone diagnostic.

[[Page 87812]]

    (v) Any instructions technicians must convey to patients regarding 
the administration of the test and collection of cognitive test data.

    Dated: November 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29134 Filed 12-5-16; 8:45 am]
 BILLING CODE 4164-01-P


