[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Rules and Regulations]
[Pages 25226-25230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10332]


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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 Lower Extremity Exoskeleton; Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; republication.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
republishing in its entirety a final order entitled ``Medical Devices; 
Physical Medicine Devices; Classification of the Powered Lower 
Extremity Exoskeleton'' that published in the Federal Register on 
February 24, 2015. FDA is republishing to correct an inadvertent 
omission of information. FDA is classifying the powered lower extremity 
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 lower extremity exoskeleton's 
classification. The Agency is classifying the device

[[Page 25227]]

into class II (special controls) in order to provide a reasonable 
assurance of safety and effectiveness of the device.

DATES: This order is effective May 4, 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, [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 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 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 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 
lower extremity exoskeleton will need to comply with the special 
controls named in this final order. The device is assigned the generic 
name powered lower extremity exoskeleton, and it is identified as a 
prescription device that is composed of an external, powered, motorized 
orthosis that is placed over a person's paralyzed or weakened limbs for 
medical purposes.
    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 Lower Extremity Exoskeleton Risks and Mitigation
                                Measures
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            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Instability, falls, and associated       Clinical testing
 injuries.
                                         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        Clinical testing
 sores, soft tissue injury.
                                         Training
                                         Labeling
Diastolic hypertension and changes in    Clinical testing
 blood pressure, and heart rate.
                                         Training

[[Page 25228]]

 
                                         Labeling
Adverse tissue reaction................  Biocompatibility assessment
Premature battery failure..............  Battery testing
                                         Labeling
Interference with other electrical       EMC/EMI testing
 equipment/devices.
                                         Labeling
Burns, electrical shock................  Electrical safety testing
                                         Thermal testing
                                         Labeling
Device malfunction resulting in          Clinical testing
 unanticipated operation (e.g., device
 stoppage, unintended movement).
                                         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:
    [cir] Mechanical bench testing (including durability testing) to 
demonstrate that the device will withstand forces, conditions, and 
environments encountered during use;
    [cir] simulated use testing (i.e., cyclic loading testing) to 
demonstrate performance of device commands and safeguard under worst 
case conditions and after durability testing;
    [cir] verification and validation of manual override controls are 
necessary, if present;
    [cir] the accuracy of device features and safeguards; and
    [cir] device functionality in terms of flame retardant materials, 
liquid/particle ingress prevention, sensor and actuator performance, 
and motor performance.
     Clinical testing must demonstrate a reasonable assurance 
of 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:
    [cir] Level of supervision necessary and
    [cir] 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:
    [cir] Identify the safe environments for device use,
    [cir] use all safety features of device, and
    [cir] 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:
    [cir] 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;
    [cir] specific instructions and the clinical training needed for 
the safe use of the device, which includes:
    [ssquf] Instructions on assembling the device in all available 
configurations;
    [ssquf] instructions on fitting the patient;
    [ssquf] instructions and explanations of all available programs and 
how to program the device;
    [ssquf] instructions and explanation of all controls, input, and 
outputs;
    [ssquf] instructions on all available modes or states of the 
device;
    [ssquf] instructions on all safety features of the device; and
    [ssquf] instructions for properly maintaining the device;
    [cir] Information on the patient population for which the device 
has been demonstrated to have a reasonable assurance of safety and 
effectiveness;
    [cir] pertinent non-clinical testing information (e.g., EMC, 
battery longevity); and
    [cir] a detailed summary of the clinical testing including:
    [ssquf] Adverse events encountered under use conditions,
    [ssquf] summary of study outcomes and endpoints, and
    [ssquf] 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 lower extremity exoskeleton devices are 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

[[Page 25229]]

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 powered lower 
extremity 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

0
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.


0
2. Revise Sec.  890.3480 to read as follows:


Sec.  890.3480  Powered lower extremity exoskeleton.

    (a) Identification. A powered lower extremity exoskeleton is a 
prescription device that is composed of an external, powered, motorized 
orthosis that is placed over a person's paralyzed or weakened limbs for 
medical purposes.
    (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 a reasonable assurance of 
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).


[[Page 25230]]


    Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10332 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P