80 FR 49136 - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

Page Range		49136-49138
FR Document		2015-20177

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.

Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015)

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


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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

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, 
[email protected].

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

49136 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Rules and Regulations

accordance with FAA Order 1050.1E, PART 73—SPECIAL USE AIRSPACE Issued in Washington, DC, on August 11,
paragraphs 402 and 404d, the FAA has 2015.
conducted an independent evaluation of ■ 1. The authority citation for part 73 M. Randy Willis,
the United States Army, Joint Readiness continues to read as follows: Acting Manager, Airspace Policy and
Training Center’s Final Environmental Authority: 49 U.S.C. 106 (f), 106(g), 40103, Regulations Group.
Assessment for the Establishment of 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, [FR Doc. 2015–20286 Filed 8–14–15; 8:45 am]
Additional Restricted Airspace Joint 1959–1963 Comp., p. 389. BILLING CODE 4910–13–P
Readiness Training Center and Fort
§ 73.38 [Amended]
Polk, LA dated March 2013 (hereinafter
‘‘the FEA’’). The FAA adopted the ■ 2. Section 73.38 is amended as DEPARTMENT OF HEALTH AND
relevant portions of the FEA and follows: HUMAN SERVICES
prepared a Finding of No Significant * * * * *
Impact/Record of Decision dated August Food and Drug Administration
R–3804A Fort Polk, LA (Amended)
11, 2015. The FAA has determined that
no significant impacts would occur as a Boundaries. Beginning at lat. 21 CFR Part 882
result of the Federal action and 31°00′53″ N., long. 93°08′12″ W.; to lat.
31°00′53″ N., long. 92°56′53″ W.; to lat. [Docket No. FDA–2015–N–2737]
therefore that preparation of an
Environmental Impact Statement is not 31°00′20″ N., long. 92°56′14″ W.; to lat.
31°00′20″ N., long. 92°54′23″ W.; to lat. Medical Devices; Neurological
warranted, and a Finding of No Devices; Classification of the
Significant Impact in accordance with 31°03′55″ N., long. 92°51′34″ W.; to lat.
31°09′35″ N., long. 92°58′25″ W.; to lat. Computerized Cognitive Assessment
40 CFR part 1501.4(e) is appropriate. Aid
Regarding amending the time of 31°09′35″ N., long. 93°00′56″ W.; to lat.
designation for R–3804A and R–3804B, 31°08′43″ N., long. 93°01′55″ W.; to lat. AGENCY: Food and Drug Administration,
the FAA has determined that this action 31°08′43″ N., long. 93°08′12″ W.; to the HHS.
qualifies for categorical exclusion under point of beginning. ACTION: Final order.
the National Environmental Policy Act Designated altitudes. Surface to FL
in accordance with FAA Order 1050.1E, 180. SUMMARY: The Food and Drug
Environmental Impacts: Policies and Time of designation. By NOTAM. Administration (FDA) is classifying the
Procedures, paragraph 311c. This Controlling agency. FAA, Houston computerized cognitive assessment aid
action, by changing time of designation ARTCC. into class II (special controls). The
from ‘‘continuous’’ to ‘‘by NOTAM’’ Using agency. U.S. Army,
special controls that will apply to the
serves to return all or part of special use Commanding General, Fort Polk, LA.
device are identified in this order, and
airspace (SUA) to the National Airspace R–3804B Fort Polk, LA (Amended) will be part of the codified language for
System (NAS). It is not expected to Boundaries. Beginning at lat. the computerized cognitive assessment
cause any potentially significant 31°00′53″ N., long. 93°10′53″ W.; to lat. aid’s classification. The Agency is
environmental impacts, and no 31°00′53″ N., long. 93°08′12″ W.; to lat. classifying the device into class II
extraordinary circumstances exists that 31°08′43″ N., long. 93°08′12″ W.; to lat. (special controls) in order to provide a
warrant preparation of an 31°08′43″ N., long. 93°11′00″ W.; to lat. reasonable assurance of safety and
environmental assessment. 31°04′56″ N., long. 93°11′00″ W.; to lat. effectiveness of the device.
Regarding making using agency 31°04′15″ N., long. 93°12′31″ W.; to the DATES: This order is effective September
corrections to R–3804A, R–3804B, and point of beginning. 16, 2015. The classification was
R–3804C, the FAA has determined that Designated altitudes. Surface to but applicable on June 5, 2015.
this action qualifies for categorical not including 10,000 feet MSL. FOR FURTHER INFORMATION CONTACT:
exclusion under the National Time of designation. By NOTAM. Peter Como, Center for Devices and
Environmental Policy Act in accordance Controlling agency. FAA, Houston Radiological Health, Food and Drug
with FAA Order 1050.1E, ARTCC. Administration, 10903 New Hampshire
Environmental Impacts: Policies and Using agency. U.S. Army, Ave., Bldg. 66, Rm. G242, Silver Spring,
Procedures, paragraph 311d. This action Commanding General, Fort Polk, LA. MD 20993–0002, 301–796–6919,
is an administrative change to the titles
R–3804C Fort Polk, LA (Amended) peter.como@fda.hhs.gov.
in the descriptions of the affected
restricted areas to reflect the correct Boundaries. Beginning at lat. SUPPLEMENTARY INFORMATION:
locations. It does not alter the 31°00′53″ N., long. 93°08′12″ W.; to lat. I. Background
dimensions, altitudes, times of 31°00′53″ N., long. 92°56′53″ W.; to lat.
designation or actual physical locations 31°00′20″ N., long. 92°56′14″ W.; to lat. In accordance with section 513(f)(1) of
of the airspace; therefore, it is not 31°00′20″ N., long. 92°54′23″ W.; to lat. the Federal Food, Drug, and Cosmetic
expected to cause any potentially 31°03′55″ N., long. 92°51′34″ W.; to lat. Act (the FD&C Act) (21 U.S.C.
significant environmental impacts, and 31°09′35″ N., long. 92°58′25″ W.; to lat. 360c(f)(1)), devices that were not in
no extraordinary circumstances exists 31°09′35″ N., long. 93°00′56″ W.; to lat. commercial distribution before May 28,
that warrant preparation of an 31°08′43″ N., long. 93°01′55″ W.; to lat. 1976 (the date of enactment of the
environmental assessment. 31°08′43″ N., long. 93°08′12″ W.; to the Medical Device Amendments of 1976),
point of beginning. generally referred to as postamendment
List of Subjects in 14 CFR Part 73 Designated altitudes. FL 180 to but devices, are classified automatically by
Airspace, Prohibited areas, Restricted not including FL 350. statute into class III without any FDA
tkelley on DSK3SPTVN1PROD with RULES

areas. Time of designation. By NOTAM 24 rulemaking process. These devices
hours in advance. remain in class III and require
Adoption of the Amendment Controlling agency. FAA, Houston premarket approval, unless and until
In consideration of the foregoing, the ARTCC. the device is classified or reclassified
Federal Aviation Administration Using agency. U.S. Army, into class I or II, or FDA issues an order
amends 14 CFR part 73 as follows: Commanding General, Fort Polk, LA. finding the device to be substantially

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Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Rules and Regulations 49137

equivalent, in accordance with section undertake the classification request if believes these special controls, in
513(i) of the FD&C Act, to a predicate FDA identifies a legally marketed device addition to general controls, will
device that does not require premarket that could provide a reasonable basis for provide reasonable assurance of the
approval. The Agency determines review of substantial equivalence with safety and effectiveness of the device.
whether new devices are substantially the device or if FDA determines that the Therefore, on June 5, 2015, FDA
equivalent to predicate devices by device submitted is not of ‘‘low- issued an order to the requestor
means of premarket notification moderate risk’’ or that general controls
classifying the device into class II. FDA
procedures in section 510(k) of the would be inadequate to control the risks
is codifying the classification of the
FD&C Act (21 U.S.C. 360(k)) and part and special controls to mitigate the risks
device by adding § 882.1470.
807 (21 CFR part 807) of the regulations. cannot be developed.
Section 513(f)(2) of the FD&C Act, as In response to a request to classify a Following the effective date of this
amended by section 607 of the Food and device under either procedure provided final classification administrative order,
Drug Administration Safety and by section 513(f)(2) of the FD&C Act, any firm submitting a premarket
Innovation Act (Pub. L. 112–144), FDA will classify the device by written notification [510(k)] for a computerized
provides two procedures by which a order within 120 days. This cognitive assessment aid will need to
person may request FDA to classify a classification will be the initial comply with the special controls named
device under the criteria set forth in classification of the device. On June 24, in the final order. The device is assigned
section 513(a)(1). Under the first 2013, Cerebral Assessment Systems, the generic name computerized
procedure, the person submits a Inc., submitted a request for cognitive assessment aid, and it is
premarket notification under section classification of the Cognivue under identified as a prescription device that
510(k) of the FD&C Act for a device that section 513(f)(2) of the FD&C Act. The uses an individual’s score(s) on a battery
has not previously been classified and, manufacturer recommended that the of cognitive tasks to provide an
within 30 days of receiving an order device be classified into class II (Ref. 1). interpretation of the current level of
classifying the device into class III In accordance with section 513(f)(2) of cognitive function. The computerized
under section 513(f)(1) of the FD&C Act, the FD&C Act, FDA reviewed the cognitive assessment aid is used only as
the person requests a classification request in order to classify the device
an assessment aid to determine level of
under section 513(f)(2). Under the under the criteria for classification set
cognitive functioning for which there
second procedure, rather than first forth in section 513(a)(1). FDA classifies
exists other valid methods of cognitive
submitting a premarket notification devices into class II if general controls
by themselves are insufficient to assessment and does not identify the
under section 510(k) of the FD&C Act
provide reasonable assurance of safety presence or absence of clinical
and then a request for classification
and effectiveness, but there is sufficient diagnoses. The computerized cognitive
under the first procedure, the person
determines that there is no legally information to establish special controls assessment aid is not intended as a
marketed device upon which to base a to provide reasonable assurance of the stand-alone or adjunctive diagnostic
determination of substantial safety and effectiveness of the device for device.
equivalence and requests a classification its intended use. After review of the FDA has identified the following risks
under section 513(f)(2) of the FD&C Act. information submitted in the request, to health associated specifically with
If the person submits a request to FDA determined that the device can be this type of device, as well as the
classify the device under this second classified into class II with the measures required to mitigate these
procedure, FDA may decline to establishment of special controls. FDA risks in table 1:

TABLE 1—COMPUTERIZED COGNITIVE ASSESSMENT AID RISKS AND MITIGATION MEASURES
Identified risk Mitigation measure

Equipment malfunction leading to subject injury (shock, burn, or me- Electrical safety testing.
chanical failure). Labeling.
User discomfort (e.g., visual fatigue, stimulus-induced nausea) ............. Labeling.
Incorrect result, inclusive of: Hardware and software verification, validation, and hazard analysis.
• False positive—cognitive impairment when, in fact, none is Labeling.
present
• False negative—cognitive impairment when, in fact, cognitive
impairment is present

FDA believes that the following Æ Software, including any proprietary device functions as an interpretation of
special controls, in addition to the algorithm(s) used by the device to arrive the current level of cognitive function.
general controls, address these risks to at its interpretation of the patient’s The summary of testing must include
health and provide reasonable assurance cognitive function, must be described in the following, if available: Any expected
of safety and effectiveness: detail in the Software Requirements or observed adverse events and
Specification (SRS) and Software Design complications; any performance
• The technical parameters of the
Specification (SDS). Appropriate measurements including sensitivity,
device’s hardware and software must be
software verification, validation, and specificity, positive predictive value
fully characterized and be accompanied hazard analysis must be performed.
tkelley on DSK3SPTVN1PROD with RULES

by appropriate non-clinical testing: (PPV), and negative predictive value
• The device must be designed and (NPV) per the device intended use; a
Æ Hardware specifications must be tested for electrical safety. description of the repeatability of
provided. Appropriate verification,
• The labeling must include: measurements; a description of how the
validation, and hazard analysis must be
Æ A summary of any testing cut-off values for categorization of
performed.
conducted to demonstrate how the measurements were determined; and a

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49138 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Rules and Regulations

description of the construct validity of IV. Reference described in detail in the software
the device. The following reference has been requirements specification (SRS) and
Æ A warning that the device does not software design specification (SDS).
placed on display in the Division of
identify the presence or absence of Appropriate software verification,
Dockets Management (HFA–305), Food
clinical diagnoses. validation, and hazard analysis must be
and Drug Administration, 5630 Fishers
Æ A warning that the device is not a performed.
Lane, Rm. 1061, Rockville, MD 20852,
stand-alone diagnostic. (2) The device must be designed and
Æ The intended use population and and may be seen by interested persons
tested for electrical safety.
the intended use environment. between 9 a.m. and 4 p.m., Monday (3) The labeling must include:
Æ Any instructions technicians must through Friday, and is available (i) A summary of any testing
convey to patients regarding the electronically at http:// conducted to demonstrate how the
administration of the test and collection www.regulations.gov. device functions as an interpretation of
of cognitive test data. 1. DEN130033: De Novo Request per 513(f)(2) the current level of cognitive function.
Computerized cognitive assessment of the Federal Food, Drug, and Cosmetic The summary of testing must include
aids are prescription devices restricted Act from Cerebral Assessment Systems, the following, if available: Any expected
to patient use only upon the Inc., dated June 24, 2013. or observed adverse events and
authorization of a practitioner licensed List of Subjects in 21 CFR Part 882 complications; any performance
by law to administer or use the device; measurements including sensitivity,
see 21 CFR 801.109 (Prescription Medical devices, Neurological specificity, positive predictive value
devices). devices. (PPV), and negative predictive value
Section 510(m) of the FD&C Act Therefore, under the Federal Food, (NPV) per the devices intended use; a
provides that FDA may exempt a class Drug, and Cosmetic Act and under description of the repeatability of
II device from the premarket notification authority delegated to the Commissioner measurements; a description of how the
requirements under section 510(k), if of Food and Drugs, 21 CFR part 882 is cut-off values for categorization of
FDA determines that premarket amended as follows: measurements were determined; and a
notification is not necessary to provide description of the construct validity of
reasonable assurance of the safety and PART 882—NEUROLOGICAL DEVICES the device.
effectiveness of the device. For this type (ii) A warning that the device does not
■ 1. The authority citation for 21 CFR
of device, FDA has determined that identify the presence or absence of
part 882 continues to read as follows:
premarket notification is necessary to clinical diagnoses.
provide reasonable assurance of the Authority: 21 U.S.C. 351, 360, 360c, 360e, (iii) A warning that the device is not
safety and effectiveness of the device. 360j, 371. a stand-alone diagnostic.
Therefore, this device type is not ■ 2. Add § 882.1470 to subpart B to read (iv) The intended use population and
exempt from premarket notification as follows: the intended use environment.
requirements. Persons who intend to (v) Any instructions technicians must
market this type of device must submit § 882.1470 Computerized cognitive convey to patients regarding the
assessment aid. administration of the test and collection
to FDA a premarket notification, prior to
marketing the device, which contains (a) Identification. The computerized of cognitive test data.
information about the computerized cognitive assessment aid is a Dated: August 11, 2015.
cognitive assessment aid they intend to prescription device that uses an Leslie Kux,
market. individual’s score(s) on a battery of
Associate Commissioner for Policy.
cognitive tasks to provide an
II. Environmental Impact interpretation of the current level of [FR Doc. 2015–20177 Filed 8–14–15; 8:45 am]
cognitive function. The computerized BILLING CODE 4164–01–P
The Agency has determined under 21
CFR 25.34(b) that this action is of a type cognitive assessment aid is used only as
that does not individually or an assessment aid to determine level of
cumulatively have a significant effect on cognitive functioning for which there DEPARTMENT OF STATE
the human environment. Therefore, exists other valid methods of cognitive
assessment and does not identify the 22 CFR Part 35
neither an environmental assessment
nor an environmental impact statement presence or absence of clinical [Public Notice 9220]
is required. diagnoses. The computerized cognitive RIN 1400–AD85
assessment aid is not intended as a
III. Paperwork Reduction Act of 1995 stand-alone or adjunctive diagnostic Program Fraud Civil Remedies
This final order establishes special device.
controls that refer to previously (b) Classification. Class II (special AGENCY: Department of State.
approved collections of information controls). The special control(s) for this ACTION: Final rule.
found in other FDA regulations. These device are:
collections of information are subject to SUMMARY: The Department of State is
(1) The technical parameters of the
review by the Office of Management and updating its regulations regarding its
device’s hardware and software must be
Budget (OMB) under the Paperwork implementation of the Program Fraud
fully characterized and be accompanied
Reduction Act of 1995 (44 U.S.C. 3501– Civil Remedies Act of 1986, to remove
by appropriate non-clinical testing:
3520). The collections of information in a conflict between the ‘‘reviewing
(i) Hardware specifications must be
part 807, subpart E regarding premarket official’’ and the ‘‘authority head’’ as
provided. Appropriate verification,
tkelley on DSK3SPTVN1PROD with RULES

notification submissions have been defined by the implementing
validation, and hazard analysis must be
approved under OMB control number regulations.
performed.
0910–0120, and the collections of (ii) Software, including any DATES: This rule is effective August 17,
information in 21 CFR part 801, proprietary algorithm(s) used by the 2015.
regarding labeling have been approved device to arrive at its interpretation of FOR FURTHER INFORMATION CONTACT:
under OMB control number 0910–0485. the patient’s cognitive function, must be Alice Kottmyer, Attorney-Adviser,

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Document Created: 2015-12-15 11:07:20
Document Modified: 2015-12-15 11:07:20

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 September 16, 2015. The classification was applicable on June 5, 2015.
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, [email protected]
FR Citation		80 FR 49136
CFR Associated		Medical Devices and Neurological Devices

80 FR 49136 - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration