
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Rules and Regulations]
[Pages 49136-49138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20177]


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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
computerized cognitive assessment aid 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'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 September 16, 2015. The classification 
was applicable on June 5, 2015.

FOR FURTHER INFORMATION CONTACT: Peter Como, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G242, Silver Spring, MD 20993-0002, 301-796-6919, 
peter.como@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 postamendment 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

[[Page 49137]]

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 will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device. On 
June 24, 2013, Cerebral Assessment Systems, Inc., submitted a request 
for classification of the Cognivue under section 513(f)(2) of the FD&C 
Act. The manufacturer recommended that the device be classified into 
class II (Ref. 1).
    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 June 5, 2015, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  882.1470.
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
[510(k)] for a computerized cognitive assessment aid will need to 
comply with the special controls named in the final order. The device 
is assigned the generic name computerized cognitive assessment aid, and 
it is identified as a prescription device that uses an individual's 
score(s) on a battery of cognitive tasks to provide an interpretation 
of the current level of cognitive function. The computerized cognitive 
assessment aid is used only as an assessment aid to determine level of 
cognitive functioning for which there exists other valid methods of 
cognitive assessment and does not identify the presence or absence of 
clinical diagnoses. The computerized cognitive assessment aid is not 
intended as a stand-alone or adjunctive diagnostic device.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the measures required 
to mitigate these risks in table 1:

   Table 1--Computerized Cognitive Assessment Aid Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Equipment malfunction leading to         Electrical safety testing.
 subject injury (shock, burn, or         Labeling.
 mechanical failure).
User discomfort (e.g., visual fatigue,   Labeling.
 stimulus-induced nausea).
Incorrect result, inclusive of:          Hardware and software
 False positive--cognitive        verification, validation, and
 impairment when, in fact, none is        hazard analysis.
 present                                 Labeling.
 False negative--cognitive
 impairment when, in fact, cognitive
 impairment is present
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
     The technical parameters of the device's hardware and 
software must be fully characterized and be accompanied by appropriate 
non-clinical testing:
    [cir] Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    [cir] 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). 
Appropriate software verification, validation, and hazard analysis must 
be performed.
     The device must be designed and tested for electrical 
safety.
     The labeling must include:
    [cir] A summary of any testing conducted to demonstrate how the 
device functions as an interpretation of the current level of cognitive 
function. The summary of testing must include the following, if 
available: Any expected or observed adverse events and complications; 
any performance measurements including sensitivity, specificity, 
positive predictive value (PPV), and negative predictive value (NPV) 
per the device intended use; a description of the repeatability of 
measurements; a description of how the cut-off values for 
categorization of measurements were determined; and a

[[Page 49138]]

description of the construct validity of the device.
    [cir] A warning that the device does not identify the presence or 
absence of clinical diagnoses.
    [cir] A warning that the device is not a stand-alone diagnostic.
    [cir] The intended use population and the intended use environment.
    [cir] Any instructions technicians must convey to patients 
regarding the administration of the test and collection of cognitive 
test data.
    Computerized cognitive assessment aids are prescription devices 
restricted to patient use only upon the authorization of a practitioner 
licensed by law to administer or use the device; 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 they intend to market.

II. 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.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

1. DEN130033: De Novo Request per 513(f)(2) of the Federal Food, 
Drug, and Cosmetic Act from Cerebral Assessment Systems, Inc., dated 
June 24, 2013.

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 21 CFR part 882 continues to read as 
follows:

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


0
2. Add Sec.  882.1470 to subpart B to read as follows:


Sec.  882.1470  Computerized cognitive assessment aid.

    (a) Identification. The computerized cognitive assessment aid is a 
prescription device that uses an individual's score(s) on a battery of 
cognitive tasks to provide an interpretation of the current level of 
cognitive function. The computerized cognitive assessment aid is used 
only as an assessment aid to determine level of cognitive functioning 
for which there exists other valid methods of cognitive assessment and 
does not identify the presence or absence of clinical diagnoses. The 
computerized cognitive assessment aid is not intended as a stand-alone 
or adjunctive diagnostic device.
    (b) Classification. Class II (special controls). The special 
control(s) for this device are:
    (1) The technical parameters of the device's hardware and software 
must be fully characterized and be accompanied by appropriate non-
clinical testing:
    (i) Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    (ii) 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). 
Appropriate software verification, validation, and hazard analysis must 
be performed.
    (2) The device must be designed and tested for electrical safety.
    (3) The labeling must include:
    (i) A summary of any testing conducted to demonstrate how the 
device functions as an interpretation of the current level of cognitive 
function. The summary of testing must include the following, if 
available: Any expected or observed adverse events and complications; 
any performance measurements including sensitivity, specificity, 
positive predictive value (PPV), and negative predictive value (NPV) 
per the devices intended use; a description of the repeatability of 
measurements; a description of how the cut-off values for 
categorization of measurements were determined; and a description of 
the construct validity of the device.
    (ii) A warning that the device does not identify the presence or 
absence of clinical diagnoses.
    (iii) A warning that the device is not a stand-alone diagnostic.
    (iv) The intended use population and the intended use environment.
    (v) Any instructions technicians must convey to patients regarding 
the administration of the test and collection of cognitive test data.

    Dated: August 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20177 Filed 8-14-15; 8:45 am]
BILLING CODE 4164-01-P


