[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Rules and Regulations]
[Pages 20779-20783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2013-N-0568]


Physical Medicine Devices; Reclassification of Stair-Climbing 
Wheelchairs

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify stair-climbing wheelchairs, a class III device, 
into class II (special controls) based on new information and subject 
to premarket notification, and further clarify the identification.

DATES: This order is effective April 14, 2014.

FOR FURTHER INFORMATION CONTACT: Mike Ryan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796-6283.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 
105-115), the Medical Device User Fee and Modernization Act of 2002 
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. 
L. 108-214), the Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85), and the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 
360c) established three categories (classes) of devices, reflecting the 
regulatory controls needed to provide reasonable assurance of their 
safety and effectiveness. The three categories of devices are class I 
(general controls), class II (special controls), and class III 
(premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as preamendments devices), are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices), are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
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).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended section 513(e) of the FD&C Act, changing the mechanism for 
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act governs reclassification of 
classified preamendments devices. This section provides that FDA may, 
by administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
of the FD&C Act or an interested person may petition FDA to reclassify 
a preamendments device. The term ``new information,'' as used in 
section 513(e) of the FD&C Act, includes information developed as a 
result of a reevaluation of the data before the Agency when the device 
was originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland-Rantos 
Co. v. United States Department of Health, Education, and Welfare, 587 
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available authority (see Bell, 366 F.2d at

[[Page 20780]]

181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or 
in light of changes in ``medical science'' (Upjohn, 422 F.2d at 951). 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in section 513(a)(3) of the 
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. 
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 
766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
premarket approval application (PMA). (See section 520(c) of the FD&C 
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by 
FDAMA, provides that FDA may use, for reclassification of a device, 
certain information in a PMA 6 years after the application has been 
approved. This includes information from clinical and preclinical tests 
or studies that demonstrate the safety or effectiveness of the device 
but does not include descriptions of methods of manufacture or product 
composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed order in the Federal Register; (2) a meeting of a device 
classification panel described in section 513(b) of the FD&C Act; and 
(3) consideration of comments to a public docket. FDA published a 
proposed order to reclassify this device in the Federal Register of 
June 12, 2013 (78 FR 35173). FDA received and has considered 285 
comments on this proposed order, as discussed in section II. FDA has 
held a meeting of a device classification panel described in section 
513(b) of the FD&C Act with respect to stair-climbing wheelchairs and, 
therefore, has met this requirement under section 513(e)(1) of the FD&C 
Act. As further described in section III, a meeting of a device 
classification panel described in section 513(b) of the FD&C Act took 
place on December 12, 2013 (78 FR 66942, November 7, 2013), to discuss 
whether stair-climbing wheelchairs should be reclassified or remain in 
class III, and the panel recommended that the device be reclassified 
into class II because there was sufficient information to establish 
special controls. FDA is not aware of new information since the panel 
that would provide a basis for a different recommendation or findings.

II. Public Comments in Response to the Proposed Order

    In response to the June 12, 2013 (78 FR 35173), proposed order to 
reclassify stair-climbing wheelchairs, FDA received 285 comments. 
Comments were received from consumers and other stakeholders who are 
personally or professionally associated with a stair-climbing 
wheelchair user. These individuals included users, family members, 
friends, and professionals such as occupational and physical 
therapists. Several veterans and patient advocacy groups also 
responded. The majority of the comments received advocated that this 
device be classified into class II, but the comments did not include 
information relevant to the safety, effectiveness, or risks of these 
devices, aside from personal experience, which focused on payment and 
availability issues and are not directly relevant to the types of 
information necessary for a classification decision. One comment from a 
representative of a patient advocacy coalition opposed the 
reclassification to class II, stating that, ``This change in 
classification would result in greater risk for some of our nation's 
most vulnerable consumers,'' and citing safety data published on FDA's 
Web site and described in section 5 of the FDA's Executive Panel 
Summary (Ref. 1), as well as the risks of the device as outlined in 
section V of the proposed order.
    The Agency disagrees with this comment regarding risks and believes 
it has identified the relevant risks to health (see section V of the 
proposed order and sections III and IV of this document) and special 
controls that will be effective in mitigating these risks (see section 
VIII of the proposed order and the codified language of this document). 
These risks and mitigations were based on the input of the original 
classification panel in 1976; data in PMAs available to FDA under 
section 520(h)(4) of the FD&C Act, added by FDAMA; the information in 
the 2012 reclassification petition (Ref. 2); the information gathered 
from FDA's Manufacturer and User Facility Device Experience (MAUDE) 
database and FDA's literature review (see FDA's Executive Panel 
Summary, Ref. 1); and the recommendations of the December 12, 2013, 
Orthopedic and Rehabilitation Devices Panel of the Medical Devices 
Advisory Committee (Ref. 3), as further described in section III of 
this document. Further, FDA believes that the identified special 
controls mitigate these risks and provide a reasonable assurance of 
safety and effectiveness in this patient population.

III. Deliberations of the Panel

    On December 12, 2013, the Orthopedic and Rehabilitation Devices 
Panel of the Medical Devices Advisory Committee (the Panel) considered 
the reclassification of stair-climbing wheelchair devices from class 
III to class II (special controls) (Ref. 3). The Panel was asked to 
provide input on the risks to health, safety, and effectiveness of 
these devices.
    The reclassification of stair-climbing wheelchair devices was 
supported by the Panel. At the Panel, FDA proposed a new identification 
for stair-climbing wheelchairs that differed from the identification 
given in the proposed order. This change was proposed to remove the 
language for endless belt tracks, and the Panel supported this 
revision. The new identification is to encompass the other modes of 
propulsion that may be used and have been approved for other stair-
climbing wheelchairs. The new proposed device identification supported 
by the Panel is, ``A stair-climbing wheelchair is a device with wheels 
that is intended for medical purposes to provide mobility to persons 
restricted to a sitting position. The device is intended to climb 
stairs.''
    The panelists agreed with the FDA's list of risks to health from 
the June 2013 proposed order related to stair-climbing wheelchairs and 
added suggestions related to pressure sores, bruising, use error, and 
falls and associated injuries. The Panel expressed concern that the 
method of sustaining injury for pressure sores and bruising is 
dramatically different as discussed in this document and recommended 
that bruising and pressure sores be presented as two separate risks. 
The Panel also requested an expansion to the description of the use 
error risk to include users injuring themselves by shifting their 
position or posture while in the device. Additionally, the Panel asked 
that subdural hematoma be specifically identified as a clinical risk to 
health, as a result of the fall. After the Panel, FDA further reviewed 
the available evidence and noted that skin rash had been identified in 
the reported adverse events and presented to the Panel. Therefore, FDA 
has amended the list of risks to include adverse tissue reactions 
(e.g., rash, irritation). FDA believes this will

[[Page 20781]]

be addressed by the existing special control (biocompatibility).
    Based upon the Panel's input and FDA's review, FDA has updated the 
risks to the following:
     Instability: Instability of the device could result in the 
device tipping over, slipping off an edge (e.g., curb or stair), or 
sliding down stairs, or use in certain environmental conditions that 
minimizes frictional coefficient, may result in injury to the user.
     Entrapment: The device may entrap a user or a body part if 
it moves unintentionally, shifts the user into a position from which 
they are unable to extricate themselves, or pinches a body part against 
a solid object.
     Use error: A stair-climbing wheelchair may be misused if 
the user is not properly secured within the seat or if the device is 
used outside of certain environmental conditions or prescribed step 
dimensions, structural characteristics. The user could also be 
positioned in the seat in such a way as to cause injury.
     Falls and associated injuries: If the user falls out of 
the chair or the device falls or rolls over a body part of the user or 
another individual (e.g., caregiver), it can result in serious injury, 
including fracture, subdural hematoma, or other injuries.
     Battery/electrical/mechanical failure: The device may fail 
and place the user in an unsafe position (e.g., middle of a street 
intersection, on stairs). This may result from failure of device 
critical device components (electronics, battery, brakes) or the device 
changing operational modes unexpectedly.
     Pressure sores: Individuals restricted to a wheelchair are 
at increased risk of pressure sores. Pressure sores develop due to 
pressure, shear force, friction and a combination of all these factors. 
Pressure sores may develop due to poor wheelchair position or 
inadequate pressure relief regimen. Pressure points can cause cell 
death and a resulting pressure sore. Pressure points are typically 
found at bony prominences, areas that are squeezed due to a poor 
fitting wheelchair, or areas with increased pressure such as the sacrum 
when a person has poor position in the wheelchair.
     Bruising: Bruising may result from the user experiencing 
jarring forces when transitioning over different surfaces or from 
colliding with solid objects.
     Burns: As a result of battery overheating, electrical 
failure, or ignition of flammable materials, the user may sustain 
burns.
     Electric shock: The user may experience electric shock as 
a result of battery or electrical failure.
     Electromagnetic interference: The device may interfere 
with the operation of other electrical devices or be susceptible to 
interference from other electrical devices.
     Adverse tissue reaction: The patient-contacting materials 
of the device may produce local adverse effects, such as skin rash or 
irritation.
    The Panel found that stair-climbing wheelchairs are not life 
supporting or life sustaining. The Panel also agreed that FDA's list of 
special controls from the June 2013 proposed order would mitigate the 
risks and provide reasonable assurance of safety and effectiveness for 
stair-climbing wheelchair devices. Panelists expressed concerns 
regarding the specificity of the proposed special controls given the 
potential variations in device designs, environmental conditions, and 
user abilities. The Panel commented that the special controls for 
endurance testing are duplicative of the tests outlined in fatigue 
testing. Panelists agreed that general controls, required for all 
medical devices, are insufficient to provide a reasonable assurance of 
safety and effectiveness for stair-climbing wheelchair devices.
    FDA agrees with the special control recommendations and has revised 
the special controls accordingly (see section IV., The Final Order). 
Table 1 shows how FDA believes that the risks to health identified and 
listed in this document can be mitigated by the special controls.

                   Table 1--Health Risks and Mitigation Measures for Stair-Climbing Wheelchair
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               Identified risk                                        Mitigation measures
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Instability.................................  Performance Testing.
                                              Usability Testing.
                                              Software Verification and Validation.
                                              Design Characteristics.
                                              Labeling.
Entrapment..................................  Performance Testing.
                                              Usability Testing.
                                              Software Verification and Validation.
                                              Labeling.
Use Error...................................  Usability Testing.
                                              Labeling.
Falls and Associated Injuries...............  Performance Testing.
                                              Usability Testing.
                                              Labeling.
Battery/Electrical/Mechanical Failure.......  Performance Testing.
                                              Electrical Safety Testing.
                                              Software Verification and Validation.
                                              Battery Testing.
                                              Labeling.
Pressure Sores..............................  Design Characteristics.
                                              Usability Testing.
                                              Labeling.
Bruising....................................  Design Characteristics.
                                              Usability Testing.
                                              Labeling.
Burns.......................................  Battery Testing.
                                              Flammability Testing.
                                              Electrical Safety Testing.
                                              Labeling.
Electrical shock............................  Battery Testing.

[[Page 20782]]

 
                                              Electrical Safety Testing.
                                              Labeling.
Electromagnetic Interference................  Electromagnetic Compatibility Testing.
                                              Labeling.
Adverse Tissue Reaction.....................  Biocompatibility Testing.
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IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings, 
in part, as published in the preamble to the proposed order. FDA has 
made revisions in this final order in response to the comments received 
(see section II) and the deliberations of the Panel (see section III). 
As published in the proposed order, FDA is issuing this final order to 
reclassify stair-climbing wheelchairs from class III to class II and 
establish special controls by revising Sec.  890.3890 (21 CFR 
890.3890). The identification for Sec.  890.3890(a) has been revised to 
provide a more accurate description of devices in this classification.
    In response to the input of the Panel, FDA also made refinements to 
the proposed special controls. FDA modified the special controls 
requirements for stair-climbing wheelchair devices including: Endurance 
testing was removed since it is duplicative of fatigue testing.
    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 devices. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of stair-climbing wheelchair devices, and therefore, this 
device type is not exempt from premarket notification requirements.

V. 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in 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 812 have been approved under 
OMB control number 0910-0078; the collections of information in part 
807, subpart E, have been approved under OMB control number 0910-0120; 
and the collections of information under 21 CFR part 801 have been 
approved under OMB control number 0910-0485.

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) as amended requires FDA to issue final orders rather 
than regulations, FDASIA also provides for FDA to revoke previously 
issued regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations (CFR). Changes resulting from final orders will appear in 
the CFR as changes to codified classification determinations or as 
newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the 
FD&C Act, as amended by FDASIA, in this final order, FDA is revoking 
the requirements in Sec.  890.3890 related to the classification of 
stair-climbing wheelchairs as class III devices and codifying the 
reclassification of stair-climbing wheelchairs into class II.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

1. FDA Executive Summary prepared for the December 12, 2013, meeting 
of the Orthopedic and Rehabilitation Panel (available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM378085.pdf).
2. Petition from Deka Research & Development Corp., October 22, 2012 
(Docket No. FDA-2012-P-1155) (available at: http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-1155-0001).
3. Transcript of the December 12, 2013, meeting of the Orthopedic 
and Rehabilitation Panel (available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM381590.pdf).

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. Section 890.3890 is revised to read as follows:


Sec.  890.3890  Stair-climbing wheelchair.

    (a) Identification. A stair-climbing wheelchair is a device with 
wheels that is intended for medical purposes to provide mobility to 
persons restricted to a sitting position. The device is intended to 
climb stairs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The design characteristics of the device must ensure that the 
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate adequate mechanical 
performance under simulated use conditions and environments. 
Performance testing must include the following:
    (i) Fatigue testing;

[[Page 20783]]

    (ii) Resistance to dynamic loads (impact testing);
    (iii) Effective use of the braking mechanism and how the device 
stops in case of an electrical brake failure;
    (iv) Demonstration of adequate stability of the device on inclined 
planes (forward, backward, and lateral);
    (v) Demonstration of the ability of the device to safely ascend and 
descend obstacles (i.e., stairs, curb); and
    (vi) Demonstration of ability to effectively use the device during 
adverse temperatures and following storage in adverse temperatures and 
humidity conditions.
    (3) The skin-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Software design, verification, and validation must demonstrate 
that the device controls, alarms, and user interfaces function as 
intended.
    (5) Appropriate analysis and performance testing must be conducted 
to verify electrical safety and electromagnetic compatibility of the 
device.
    (6) Performance testing must demonstrate battery safety and 
evaluate longevity.
    (7) Performance testing must evaluate the flammability of device 
components.
    (8) Patient labeling must bear all information required for the 
safe and effective use of the device, specifically including the 
following:
    (i) A clear description of the technological features of the device 
and the principles of how the device works;
    (ii) A clear description of the appropriate use environments/
conditions, including prohibited environments;
    (iii) Preventive maintenance recommendations;
    (iv) Operating specifications for proper use of the device such as 
patient weight limitations, device width, and clearance for 
maneuverability; and
    (v) A detailed summary of the device-related adverse events and how 
to report any complications.
    (9) Clinician labeling must include all the information in the 
Patient labeling noted in paragraph (b)(8) of this section but must 
also include the following:
    (i) Identification of patients who can effectively operate the 
device; and
    (ii) Instructions on how to fit, modify, or calibrate the device.
    (10) Usability studies of the device must demonstrate that the 
device can be used by the patient in the intended use environment with 
the instructions for use and user training.

    Dated: April 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08257 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P