16266 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

* * * * * 

By direction of the Commission. 

Donald S. Clark 

Secretary. 

[FR Doc. 2015–07070 Filed 3–26–15; 8:45 am] 

BILLING CODE 6750–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2015–N–0802] 

Medical Devices; Neurological 

Devices; Classification of the Brain 

Injury Adjunctive Interpretive 

Electroencephalograph Assessment 

Aid 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

brain injury adjunctive interpretive 

electroencephalograph 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 brain injury adjunctive interpretive 

electroencephalograph 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 March 27, 

2015. The classification was applicable 

on November 17, 2014. 

FOR FURTHER INFORMATION CONTACT: Jay 

Gupta, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G312, Silver Spring, 

MD 20993–0002, 301–796–2795, 

jay.gupta@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 postamendments 

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 


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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 16267 

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 ‘‘lowmoderate 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 August 20, 2014, BrainScope 

Company, Inc., submitted a request for 

classification of the BrainScope Ahead 

100, Models CV–100 and M–100 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 November 17, 2014, 

FDA issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 882.1450. 

Following the effective date of this 

final classification order, any firm 

submitting a premarket notification 

(510(k)) for a brain injury adjunctive 

interpretive electroencephalograph 

assessment aid will need to comply 

with the special controls named in this 

final order. The device is assigned the 

generic name brain injury adjunctive 

interpretive electroencephalograph 

assessment aid, and it is identified as a 

prescription device that uses a patient’s 

electroencephalograph (EEG) to provide 

an interpretation of the structural 

condition of the patient’s brain in the 

setting of trauma. A brain injury 

adjunctive interpretive EEG assessment 

aid is for use as an adjunct to standard 

clinical practice only as an assessment 

aid for a medical condition for which 

there exists other valid methods of 

diagnosis. 

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. 

TABLE 1—BRAIN INJURY ADJUNCTIVE INTERPRETIVE ELECTROENCEPHALOGRAPH ASSESSMENT AID RISKS AND MITIGATION

MEASURES

Identified risk Mitigation measure 

Adverse tissue reaction ............................................................................ Biocompatibility. 

Labeling. 

Equipment malfunction leading to injury to user/patient (shock, burn, or 

mechanical failure).

Electrical safety, thermal, and mechanical testing. 

Electromagnetic compatibility testing. 

Labeling. 

Delay in treatment or unnecessary treatment due to hardware or software failure.Performance testing. 

Hardware and software verification, validation and hazard analysis. 

Electromagnetic compatibility testing. 

Technical parameters 

Labeling. 

False result due to incorrect artifact reduction ......................................... Software verification and validation. 

Labeling. 

False result due to incorrect placement of electrodes ............................. Clinical performance testing. 

Labeling. 

False result when a brain injury adjunctive interpretive EEG assessment aid impacts the clinical decision.Clinical performance testing. 

Device design characteristics. 

Labeling. 

Use error ................................................................................................... Clinical performance testing. 

Labeling. 

FDA believes that the following 

special controls, in combination with 

the general controls, address these risks 

to health and provide reasonable 

assurance of the safety and 

effectiveness: 

• The technical parameters of the 

device, hardware and software, must be 

fully characterized and include the 

following information: 

Æ Hardware specifications must be 

provided. Appropriate verification, 

validation, and hazard analysis must be 

performed. 

Æ Software, including any proprietary 

algorithm(s) used by the device to arrive 

at its interpretation of the patient’s 

condition, 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 parts that contact the 

patient must be demonstrated to be 

biocompatible. 

• The device must be designed and 

tested for electrical safety, 

electromagnetic compatibility (EMC), 

thermal, and mechanical safety. 

• Clinical performance testing must 

demonstrate the accuracy, precisionrepeatability and reproducibility, of 

determining the EEG-based 


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interpretation, including any specified 

equivocal zones (cut-offs). 

• Clinical performance testing must 

demonstrate the ability of the device to 

function as an assessment aid for the 

medical condition for which the device 

is indicated. Performance measures 

must demonstrate device performance 

characteristics per the intended use in 

the intended use environment. 

Performance measurements must 

include sensitivity, specificity, positive 

predictive value (PPV), and negative 

predictive value (NPV) with respect to 

the study prevalence per the device 

intended use. 

• The device design must include 

safeguards to ensure appropriate clinical 

interpretation of the device output (e.g., 

use in appropriate patient population, 

or for appropriate clinical decision). 

• The labeling and training 

information must include: 

Æ A warning that the device is not to 

be used as a stand-alone diagnostic. 

Æ A detailed summary of the clinical 

performance testing, including any 

adverse events and complications. 

Æ The intended use population and 

the intended use environment. 

Æ Any instructions technicians 

should convey to patients regarding the 

collection of EEG data. 

Æ Information allowing clinicians to 

gauge clinical risk associated with 

integrating the EEG interpretive 

assessment aid into their diagnostic 

pathway. 

Æ Information allowing clinicians to 

understand how to integrate the device 

output into their diagnostic pathway 

when the device is unable to provide a 

classification or final result. 

Brain injury adjunctive interpretive 

electroencephalograph assessment aid 

devices 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)). Prescription-use restrictions 

are a type of general controls as defined 

in section 513(a)(1)(A)(i) of the FD&C 

Act. 

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) of the 

FD&C Act, 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 brain injury adjunctive 

interpretive electroencephalograph 

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 

21 CFR 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. [DEN140025]: De Novo Request per 

513(f)(2) from BrainScope Company, Inc., 

dated August 20, 2014. 

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 

■ 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. 

■ 2. Add § 882.1450 to subpart B to read 

as follows: 

§ 882.1450 Brain injury adjunctive 

interpretive electroencephalograph 

assessment aid. 

(a) Identification. A brain injury 

adjunctive interpretive 

electroencephalograph assessment aid is 

a prescription device that uses a 

patient’s electroencephalograph (EEG) 

to provide an interpretation of the 

structural condition of the patient’s 

brain in the setting of trauma. A brain 

injury adjunctive interpretive EEG 

assessment aid is for use as an adjunct 

to standard clinical practice only as an 

assessment aid for a medical condition 

for which there exists other valid 

methods of diagnosis. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The technical parameters of the 

device, hardware and software, must be 

fully characterized and include the 

following information: 

(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 condition, 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 parts that contact the 

patient must be demonstrated to be 

biocompatible. 

(3) The device must be designed and 

tested for electrical safety, 

electromagnetic compatibility (EMC), 

thermal, and mechanical safety. 

(4) Clinical performance testing must 

demonstrate the accuracy, precisionrepeatability and reproducibility, of 

determining the EEG-based 

interpretation, including any specified 

equivocal zones (cutoffs). 

(5) Clinical performance testing must 

demonstrate the ability of the device to 

function as an assessment aid for the 

medical condition for which the device 

is indicated. Performance measures 

must demonstrate device performance 

characteristics per the intended use in 

the intended use environment. 

Performance measurements must 

include sensitivity, specificity, positive 

predictive value (PPV), and negative 

predictive value (NPV) with respect to 

the study prevalence per the device 

intended use. 

(6) The device design must include 

safeguards to ensure appropriate clinical 

interpretation of the device output (e.g., 


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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 16269 

use in appropriate patient population, 

or for appropriate clinical decision). 

(7) The labeling and training 

information must include: 

(i) A warning that the device is not to 

be used as a stand-alone diagnostic. 

(ii) A detailed summary of the clinical 

performance testing, including any 

adverse events and complications. 

(iii) The intended use population and 

the intended use environment. 

(iv) Any instructions technicians 

should convey to patients regarding the 

collection of EEG data. 

(v) Information allowing clinicians to 

gauge clinical risk associated with 

integrating the EEG interpretive 

assessment aid into their diagnostic 

pathway. 

(vi) Information allowing clinicians to 

understand how to integrate the device 

output into their diagnostic pathway 

when the device is unable to provide a 

classification or final result. 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07010 Filed 3–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 66 

[Docket ID: DOD–2011–OS–0099] 

RIN 0790–AI78 

Qualification Standards for Enlistment, 

Appointment, and Induction 

AGENCY: Office of the Under Secretary of 

Defense for Personnel and Readiness, 

DoD. 

ACTION: Interim final rule. 

SUMMARY: This rule updates policies and 

responsibilities for basic entrance 

qualification standards for enlistment, 

appointment, and induction into the 

Armed Forces and delegates the 

authority to specify certain standards to 

the Secretaries of the Military 

Departments. It establishes the age, 

aptitude, character/conduct, citizenship, 

dependents, education, medical, 

physical fitness, and other disqualifying 

conditions that are causes for rejection 

from military service. Other standards 

may be prescribed in the event of 

mobilization or national emergency. 

This rule sets standards designed to 

ensure that individuals under 

consideration for enlistment, 

appointment, and/or induction are able 

to perform military duties successfully, 

and to select those who are the most 

trainable and adaptable to Service life. 

DATES: Effective Date: This rule is 

effective March 27, 2015. Comments 

must be received by May 26, 2015. 

ADDRESSES: You may submit comments, 

identified by docket number and or 

Regulatory Information Number (RIN) 

and title, by any of the following 

methods: 

• Federal Rulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 4800 Mark Center Drive, 

2nd Floor, East Tower, Suite 02G09, 

Alexandria, VA 22350–3100. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http://

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

Dennis J. Drogo, (703) 697–9268. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

I. Purpose of This Regulatory Action 

This rule updates policies and 

responsibilities for basic entrance 

qualification standards for enlistment, 

appointment, and induction into the 

Armed Forces and delegates the 

authority to specify certain standards to 

the Secretaries of the Military 

Departments. 

II. Summary of the Major Provisions of 

This Regulatory Action 

(a) Establishes age, aptitude, 

character/conduct, citizenship, 

dependents, education, medical, 

physical fitness, and other disqualifying 

conditions that are causes for rejection 

from military service. Other standards 

may be prescribed in the event of 

mobilization or national emergency. 

(b) Sets standards designed to ensure 

that individuals under consideration for 

enlistment, appointment, and/or 

induction are able to perform military 

duties successfully and to select those 

who are the most trainable and 

adaptable to Service life. 

(c) Removes provisions related to 

homosexual conduct. 

III. Costs and Benefits of This 

Regulatory Action 

The benefit of publishing this interim 

final rule is that it establishes standards 

to ensure that those who are enlisted, 

appointed, or inducted are the best 

qualified to complete their prescribed 

training and the best able to adapt to the 

military life. Failure to maintain these 

standards would result in a high 

attrition of personnel and would 

significantly increase training costs. The 

success of today’s All-volunteer military 

is dependent on this policy. 

Justification for Interim Final Rule 

This rule is being published as an 

interim final rule to provide required 

updates in DoD policy and procedures 

that impact the public. It has been 

almost 10 years since these policies and 

procedures have been updated. Some 

policy changes and court decisions have 

a great impact on the eligibility of 

potential applicants entry into the 

military. All language addressing 

homosexual conduct has been removed 

in accordance with the December 22, 

2010, repeal of the Don’t Ask Don’t Tell 

policy, which opened military service to 

homosexuals, and the subsequent 

United States vs. Windsor decision (570 

U.S. 12, 133 S. Ct 2675 (2013)) which 

found section 3 of the Defense of 

Marriage Act (DOMA) unconstitutional. 

By removing all references to 

homosexuality, otherwise qualified 

applicants are now free to apply and 

enroll in a military academy without 

prejudice or fear of reprisal. This 

interim rule is required immediately to 

remove any legal and policy restrictions 

which would prevent a potential 

applicant from entry into a military 

based solely on their sexual orientation. 

It is important for DoD to have current 

and up-to-date enlistment, appointment, 

and induction standards, which are 

essential in defining the measures 

necessary to evaluate and qualify 

civilians for military service. A critical 

component of this update is the 

clarification of one of the underlying 

purposes of the enlistment, 

appointment, and induction standards 

which is to minimize entrance of 

persons who are likely to become 

disciplinary cases, security risks, or who 

are likely to disrupt good order, morale, 

and discipline. The Military Services 

are responsible for the defense of the 

Nation and should not be viewed as a 

source of rehabilitation for those who 

have not subscribed to the legal and 

moral standards of society at-large. The 

necessity of publishing these current 

standards, as an interim final rule, is 

vital to the DoD meeting its mission to 

man the All Volunteer Force with 

qualified citizens. 


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