9600 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations 

21 5 U.S.C. 601–612. 22SBA Final Rule on ‘‘Small Business Size 

Standards: Utilities,’’ 78 FR 77,343 (Dec. 23, 2013). 23 13 CFR 121.201, Sector 22, Utilities. 24The Small Business Administration sets the 

threshold for what constitutes a small business. 

Public utilities may fall under one of several 

different categories, each with a size threshold 

based on the company’s number of employees, 

including affiliates, the parent company, and 

subsidiaries. The possible categories for the 

applicable entities have a size threshold ranging 

from 250 employees to 1,000 employees. For the 

analysis in this proposed rule, we are using the 

1,000 employee threshold for each applicable entity 

type. 

25Regulations Implementing the National 

Environmental Policy Act of 1969, Order No. 486, 

52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs., 

Regulations Preambles 1986–1990 ¶ 30,783 (1987). 

26 18 CFR 380.4(a)(2)(ii). 

information collection, communication 

and management within the energy 

industry. The Commission has assured 

itself, by means of internal review, that 

there is specific, objective support for 

the burden estimates associated with the 

information requirements. 

Interested persons may obtain 

information on the reporting 

requirements by contacting: Federal 

Energy Regulatory Commission, 888 

First Street NE., Washington, DC 20426 

[Attention: Ellen Brown, Office of the 

Executive Director, email: 

DataClearance@ferc.gov, Phone: (202) 

502–8663, fax: (202) 273–0873]. 

Comments on the requirements of this 

rule may also be sent to the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Washington, DC 20503 [Attention: Desk 

Officer for the Federal Energy 

Regulatory Commission]. For security 

reasons, comments should be sent by 

email to OMB at oira_submission@

omb.eop.gov. Comments submitted to 

OMB should refer to FERC–725L and 

OMB Control No. 1902–0261. 

V. Regulatory Flexibility Act 

Certification 

24. The Regulatory Flexibility Act of 

1980 (RFA) 21 generally requires a 

description and analysis of final rules 

that will have significant economic 

impact on a substantial number of small 

entities. 

25. The Small Business 

Administration (SBA) revised its size 

standard (effective January 22, 2014) for 

electric utilities from a standard based 

on megawatt hours to a standard based 

on the number of employees, including 

affiliates.22 Under SBA’s new size 

standards, transmission owners and 

transmission operators likely come 

under the following category and 

associated size threshold: Electric bulk 

power transmission and control, at 500 

employees.23 The Reliability Standard 

applies to 561 entities. Comparison of 

the applicable entities with the 

Commission’s small business data 

indicates that approximately 249 are 

small entities.24 Of these, the 

Commission estimates that 

approximately five percent, or twelve of 

these small entities expect to be affected 

by the new requirements of the 

proposed Reliability Standard. The 

Commission estimates that the small 

entities that will be affected by 

Reliability Standard MOD–031–1 will 

incur one-time compliance costs ranging 

up to $14,309 (i.e. the cost of 

determining the method of weather 

normalizing annual peak hour actual 

demand), plus the annual development 

of summary narratives in accordance 

with Requirement R1, Subparts 1.5.4 

and 1.5.5, resulting in costs of $477. 

26. Accordingly, the Commission 

certifies that the Reliability Standard 

will not have a significant economic 

impact on a substantial number of small 

entities. 

VI. Environmental Analysis 

27. The Commission is required to 

prepare an Environmental Assessment 

or an Environmental Impact Statement 

for any action that may have a 

significant adverse effect on the human 

environment.25 The Commission has 

categorically excluded certain actions 

from this requirement as not having a 

significant effect on the human 

environment. Included in the exclusion 

are rules that are clarifying, corrective, 

or procedural or that do not 

substantially change the effect of the 

regulations being amended.26 The 

actions proposed herein fall within this 

categorical exclusion in the 

Commission’s regulations. 

VII. Document Availability 

28. In addition to publishing the full 

text of this document in the Federal 

Register, the Commission provides all 

interested persons an opportunity to 

view and/or print the contents of this 

document via the Internet through the 

Commission’s Home Page (http://

www.ferc.gov) and in the Commission’s 

Public Reference Room during normal 

business hours (8:30 a.m. to 5:00 p.m. 

Eastern time) at 888 First Street NE., 

Room 2A, Washington, DC 20426. 

29. From the Commission’s Home 

Page on the Internet, this information is 

available on eLibrary. The full text of 

this document is available on eLibrary 

in PDF and Microsoft Word format for 

viewing, printing, and/or downloading. 

To access this document in eLibrary, 

type the docket number excluding the 

last three digits of this document in the 

docket number field. 

30. User assistance is available for 

eLibrary and the Commission’s Web site 

during normal business hours from the 

Commission’s Online Support at 202– 

502–6652 (toll free at 1–866–208–3676) 

or email at ferconlinesupport@ferc.gov, 

or the Public Reference Room at (202) 

502–8371, TTY (202) 502–8659. Email 

the Public Reference Room at 

public.referenceroom@ferc.gov. 

VIII. Effective Date and Congressional 

Notification 

31. These regulations are effective 

April 27, 2015. The Commission has 

determined, with the concurrence of the 

Administrator of the Office of 

Information and Regulatory Affairs of 

OMB, that this rule is not ‘‘major rule’’ 

as defined in section 351 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. 

By the Commission. 

Issued: February 19, 2015. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

[FR Doc. 2015–03740 Filed 2–23–15; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 890 

[Docket No. FDA–2014–N–1903] 

Medical Devices; Physical Medicine 

Devices; Classification of the Powered 

Exoskeleton 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

powered exoskeleton 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 powered 

exoskeleton’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 26, 

2015. The classification was applicable 

on June 26, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Michael Hoffmann, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1434, Silver Spring, 

MD 20993–0002, 301–796–6476, 

Michael.Hoffmann@fda.hhs.gov. 


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Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations 9601 

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 (Public Law 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 ‘‘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 June 22, 2013, Argo Medical 

Technologies, Inc., submitted a request 

for classification of the ReWalk 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 26, 2014, 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 890.3480. 

Following the effective date of this 

final classification order, any firm 

submitting a premarket notification 

(510(k)) for a powered exoskeleton will 

need to comply with the special 

controls named in this final order. The 

device is assigned the generic name 

powered exoskeleton, and it is 

identified as a prescription device that 

is composed of an external, powered, 

motorized orthosis used for medical 

purposes that is placed over a person’s 

paralyzed or weakened limbs for the 

purpose of providing ambulation. 

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—POWERED EXOSKELETON RISKS AND MITIGATION MEASURES

Identified risk Mitigation measure 

Instability, falls, and associated injuries ................................................... Clinical testing. 

Training. 

Software verification, validation, and hazard analysis. 

Wireless testing. 

Electromagnetic compatibility (EMC) and electromagnetic interference 

(EMI) testing. 

Electrical safety testing. 

Design characteristics. 

Non-clinical performance testing. 

Water/particle ingress testing. 

Durability testing. 

Battery testing. 

Labeling. 

Bruising, skin abrasion, pressure sores, soft tissue injury ....................... Clinical testing. 

Training. 

Labeling. 

Diastolic hypertension and changes in blood pressure, and heart rate .. Clinical testing. 

Training. 

Labeling. 

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

Premature battery failure .......................................................................... Battery testing. 

Labeling. 

Interference with other electrical equipment/devices ............................... EMC/EMI testing. 

Labeling. 


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9602 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations 

TABLE 1—POWERED EXOSKELETON RISKS AND MITIGATION MEASURES—Continued 

Identified risk Mitigation measure 

Burns, electrical shock ............................................................................. Electrical safety testing. 

Thermal testing. 

Labeling. 

Device malfunction resulting in unanticipated operation (e.g., device 

stoppage, unintended movement).

Clinical testing. 

Non-clinical performance testing. 

Training. 

Software verification, validation, and hazard analysis. 

Electrical safety testing. 

Battery testing. 

Water/particle ingress testing. 

Wireless testing. 

EMC/EMI testing. 

Flammability testing. 

Labeling. 

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

Training. 

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: 

• Elements of the device materials 

that may contact the patient must be 

demonstrated to be biocompatible. 

• Appropriate analysis/testing must 

validate electronic compatibility/

interference (EMC/EMI), electrical 

safety, thermal safety, mechanical 

safety, battery performance and safety, 

and wireless performance, if applicable. 

• Appropriate software verification, 

validation, and hazard analysis must be 

performed. 

• Design characteristics must ensure 

geometry and materials composition are 

consistent with intended use. 

• Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. Performance testing 

must include: 

Æ Mechanical bench testing 

(including durability testing) to 

demonstrate that the device will 

withstand forces, conditions, and 

environments encountered during use; 

Æ simulated use testing (i.e., cyclic 

loading testing) to demonstrate 

performance of device commands and 

safeguard under worst case conditions 

and after durability testing; 

Æ verification and validation of 

manual override controls are necessary, 

if present; 

Æ the accuracy of device features and 

safeguards; and 

Æ device functionality in terms of 

flame retardant materials, liquid/

particle ingress prevention, sensor and 

actuator performance, and motor 

performance. 

• Clinical testing must demonstrate 

safe and effective use and capture any 

adverse events observed during clinical 

use when used under the proposed 

conditions of use, which must include 

considerations for: 

Æ Level of supervision necessary and 

Æ environment of use (e.g., indoors 

and/or outdoors), including obstacles 

and terrain representative of the 

intended use environment. 

• A training program must be 

included with sufficient educational 

elements so that upon completion of 

training program, the clinician, user, 

and companion can: 

Æ Identify the safe environments for 

device use, 

Æ use all safety features of device, and 

Æ operate the device in simulated or 

actual use environments representative 

of indicated environments and use. 

• Labeling for the Physician and User 

must include the following: 

Æ Appropriate instructions, warning, 

cautions, limitations, and information 

related to the necessary safeguards of 

the device, including warning against 

activities and environments that may 

put the user at greater risk; 

Æ specific instructions and the 

clinical training needed for the safe use 

of the device, which includes: 

D Instructions on assembling the 

device in all available configurations; 

D instructions on fitting the patient; 

D instructions and explanations of all 

available programs and how to program 

the device; 

D instructions and explanation of all 

controls, input, and outputs; 

D instructions on all available modes 

or states of the device; 

D instructions on all safety features of 

the device; and 

D instructions for properly 

maintaining the device; 

Æ Information on the patient 

population for which the device has 

been demonstrated to have a reasonable 

assurance of safety and effectiveness; 

Æ pertinent non-clinical testing 

information (e.g., EMC, battery 

longevity); and 

Æ a detailed summary of the clinical 

testing including: 

D Adverse events encountered under 

use conditions, 

D summary of study outcomes and 

endpoints, and 

D information pertinent to use of the 

device including the conditions under 

which the device was studied (e.g., level 

of supervision or assistance, and 

environment of use (e.g., indoors and/or 

outdoors) including obstacles and 

terrain). 

Powered exoskeleton devices are 

restricted to patient use only upon the 

authorization of a practitioner licensed 

by law to administer or use the device; 

see section 520(e) of the FD&C Act (21 

U.S.C. 360j(e)) and 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations 9603 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the powered exoskeleton 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. K131798: De Novo Request per 513(f)(2) 

from Argo Medical Technologies, Inc., dated 

June 22, 2013. 

List of Subjects in 21 CFR Part 890 

Medical devices, Physical medicine 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 890 is 

amended as follows: 

PART 890—PHYSICAL MEDICINE 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 890 continues to read as follows: 

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

360j, 371. 

■ 2. Add § 890.3480 to subpart D to read 

as follows: 

§ 890.3480 Powered exoskeleton. 

(a) Identification. A powered 

exoskeleton is a prescription device that 

is composed of an external, powered, 

motorized orthosis used for medical 

purposes that is placed over a person’s 

paralyzed or weakened limbs for the 

purpose of providing ambulation. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Elements of the device materials 

that may contact the patient must be 

demonstrated to be biocompatible. 

(2) Appropriate analysis/testing must 

validate electromagnetic compatibility/

interference (EMC/EMI), electrical 

safety, thermal safety, mechanical 

safety, battery performance and safety, 

and wireless performance, if applicable. 

(3) Appropriate software verification, 

validation, and hazard analysis must be 

performed. 

(4) Design characteristics must ensure 

geometry and materials composition are 

consistent with intended use. 

(5) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. Performance testing 

must include: 

(i) Mechanical bench testing 

(including durability testing) to 

demonstrate that the device will 

withstand forces, conditions, and 

environments encountered during use; 

(ii) Simulated use testing (i.e., cyclic 

loading testing) to demonstrate 

performance of device commands and 

safeguard under worst case conditions 

and after durability testing; 

(iii) Verification and validation of 

manual override controls are necessary, 

if present; 

(iv) The accuracy of device features 

and safeguards; and 

(v) Device functionality in terms of 

flame retardant materials, liquid/

particle ingress prevention, sensor and 

actuator performance, and motor 

performance. 

(6) Clinical testing must demonstrate 

safe and effective use and capture any 

adverse events observed during clinical 

use when used under the proposed 

conditions of use, which must include 

considerations for: 

(i) Level of supervision necessary, and 

(ii) Environment of use (e.g., indoors 

and/or outdoors) including obstacles 

and terrain representative of the 

intended use environment. 

(7) A training program must be 

included with sufficient educational 

elements so that upon completion of 

training program, the clinician, user, 

and companion can: 

(i) Identify the safe environments for 

device use, 

(ii) Use all safety features of device, 

and 

(iii) Operate the device in simulated 

or actual use environments 

representative of indicated 

environments and use. 

(8) Labeling for the Physician and 

User must include the following: 

(i) Appropriate instructions, warning, 

cautions, limitations, and information 

related to the necessary safeguards of 

the device, including warning against 

activities and environments that may 

put the user at greater risk. 

(ii) Specific instructions and the 

clinical training needed for the safe use 

of the device, which includes: 

(A) Instructions on assembling the 

device in all available configurations; 

(B) Instructions on fitting the patient; 

(C) Instructions and explanations of 

all available programs and how to 

program the device; 

(D) Instructions and explanation of all 

controls, input, and outputs; 

(E) Instructions on all available modes 

or states of the device; 

(F) Instructions on all safety features 

of the device; and 

(G) Instructions for properly 

maintaining the device. 

(iii) Information on the patient 

population for which the device has 

been demonstrated to have a reasonable 

assurance of safety and effectiveness. 

(iv) Pertinent non-clinical testing 

information (e.g., EMC, battery 

longevity). 

(v) A detailed summary of the clinical 

testing including: 

(A) Adverse events encountered 

under use conditions, 

(B) Summary of study outcomes and 

endpoints, and 

(C) Information pertinent to use of the 

device including the conditions under 

which the device was studied (e.g., level 

of supervision or assistance, and 

environment of use (e.g., indoors and/or 

outdoors) including obstacles and 

terrain). 

Dated: February 18, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03692 Filed 2–23–15; 8:45 am] 

BILLING CODE 4164–01–P 


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