[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Proposed Rules]
[Pages 35173-35178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13864]


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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: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
administrative 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 to further clarify the 
identification.

DATES: Submit either electronic or written comments on this proposed 
order or on the draft guideline by September 10, 2013. See section XII 
for the proposed effective date of any final order that may publish 
based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0568 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:

[[Page 35174]]

     Mail/Hand Delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0568. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, 
Silver Spring, MD 20993, 301-796-6527.

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.
    A preamendments device that has been classified into class III may 
be marketed by means of premarket notification procedures (510(k) 
process) without submission of a premarket approval application (PMA) 
until FDA issues a final regulation under section 515(b) of the FD&C 
Act (21 U.S.C. 360e(b)) requiring premarket approval.
    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).
    The Safe Medical Devices Act of 1990 (Pub. L. 101-629) changed the 
definition of class II devices from those for which a performance 
standard is necessary to provide reasonable assurance of safety and 
effectiveness to those for which there is sufficient information to 
establish special controls to provide such assurance. Special controls 
include performance standards.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 
Stat. 1056) amended the device reclassification procedures under 
section 513(e) of the FD&C Act, changing the process from rulemaking to 
an administrative order. 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. The proposed 
reclassification order must set forth the proposed reclassification and 
a substantive summary of the valid scientific evidence concerning the 
proposed reclassification, including the public health benefits of the 
use of the device, and the nature and incidence (if known) of the risk 
of the device. (See section 513(e)(1)(A)(i) of the FD&C Act.) As 
required by section 513(b) of the FD&C Act, FDA intends to schedule a 
panel meeting to discuss the proposed reclassification prior to issuing 
a final order.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
or an interested person may petition FDA. 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 Dep't of Health, Educ., & 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 181; 
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in 
light of changes in ``medical science'' (Upjohn v. Finch, 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 Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., 
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens 
Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 
U.S. 1062 (1985).)
    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 
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

[[Page 35175]]

that FDA may use, for reclassification of a device, certain information 
in a PMA 6 years after the application has been approved. This can 
include 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.
    FDAMA added section 510(m) to the FD&C Act (21 U.S.C. 360(m)). 
Section 510(m) of the FD&C Act provides that a class II device may be 
exempted from the premarket notification requirements under section 
510(k) of the FD&C Act, if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device.

II. Regulatory History of the Device

    On August 28, 1979 (44 FR 50497), FDA published a document 
proposing to classify stair-climbing wheelchair devices as class III 
requiring premarket approval. The Physical Medicine Device 
Classification Panel (Panel) recommended class III because the Panel 
believed that satisfactory performance of this device had not been 
demonstrated and, therefore, that it was not possible to establish an 
adequate performance standard for the device. The Panel said the design 
of the device was experimental and data to support its safe and 
effective use was not available. The Panel said the device should, 
therefore, be subject to premarket approval to assure that 
manufacturers demonstrate satisfactory performance of the device and 
thus assure its safety and effectiveness. No comments were received on 
the proposed rule. On November 23, 1983 (48 FR 53032), FDA published a 
document classifying stair-climbing wheelchairs as class III devices. 
On May 11, 1987 (52 FR 17732 at 17741), FDA published a document 
amending the codified language for stair-climbing wheelchairs to 
clarify that no effective date had been established for the requirement 
for premarket approval.
    On August 18, 1998 (63 FR 44177), FDA published a document 
proposing to require the filing of a PMA or a notice of competition of 
a product development protocol (PDP) for stair-climbing wheelchair 
devices under section 515(b) of the FD&C Act. FDA received no comments 
on the document but received one citizen petition requesting a change 
in the classification of the stair-climbing wheelchair from class III 
to class II. FDA reviewed the petition and determined that there was 
not sufficient information to establish special controls to reasonably 
assure the safety and effectiveness of the device. FDA informed the 
petitioner in a letter dated May 10, 1999, that if additional 
information was submitted under section 513(e) of the FD&C Act within 
30 days to support the reclassification of the device, FDA would review 
the information. FDA also stated that if the petitioner did not submit 
additional information within 30 days to show that sufficient 
information was available to establish special controls to reasonably 
assure the safety and effectiveness of the device, FDA would deem the 
reclassification petition withdrawn. FDA did not receive any new 
information from the petitioner and deemed the reclassification 
petition withdrawn. On April 13, 2000 (65 FR 19833), FDA published a 
document that retained in class III stair-climbing wheelchair devices 
and that required the filing of PMAs or PDPs on or before July 12, 
2000.
    On November 20, 2012, a reclassification petition was filed with 
FDA, requesting FDA to reclassify stair-climbing wheelchairs from class 
III to class II. In accordance with section 513(e) of the FD&C Act and 
Sec.  860.130(b)(3), based on new information regarding the device, FDA 
is now proposing to reclassify the stair-climbing wheelchair device 
from class III to class II.

III. Device Description

    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 and is intended to climb stairs while the patient 
remains in the chair. Characteristics of the device enabling this 
capability may include two endless belt tracks that adjust to the angle 
of the stairs. This may also include a balancing mechanism to steady 
the chair as it ascends/descends the staircase.
    FDA is proposing in this order to slightly modify the 
identification language from how it is presently written in Sec.  
890.3890(a) (21 CFR 890.3890(a)) for a more accurate description of 
devices in this classification.

IV. Proposed Reclassification

    FDA is proposing that stair-climbing wheelchairs be reclassified 
from class III to class II. In this proposed order, the Agency has 
identified special controls under section 513(a)(1)(B) of the FD&C Act 
that, together with general controls (including prescription use 
restrictions) applicable to the devices, would provide reasonable 
assurance of their safety and effectiveness. FDA believes that the 
identified special controls in this proposed order, if finalized, 
together with general controls applicable to the device, would provide 
reasonable assurance of safety and effectiveness. Absent the special 
controls identified in this proposed order, general controls applicable 
to the device are insufficient to provide reasonable assurance of the 
safety and effectiveness of the device.
    Therefore, in accordance with sections 513(e) of the FD&C Act and 
Sec.  860.130, based on new information with respect to the devices and 
taking into account the public health benefit of the use of the device 
and the nature and known incidence of the risk of the device, FDA is 
proposing to reclassify this preamendments class III device into class 
II. FDA believes that this new information is sufficient to demonstrate 
that the proposed special controls can effectively mitigate the risks 
to health identified in section V, and that these special controls, 
together with general controls, will provide a reasonable assurance of 
safety and effectiveness for stair-climbing wheelchairs.
    Section 510(m) of the FD&C Act authorizes the Agency to exempt 
class II devices from premarket notification (510(k)) submission. FDA 
has considered stair-climbing wheelchairs in accordance with the 
reserved criteria set forth in section 513(a) of the FD&C Act and 
determined that these devices require premarket notification. 
Therefore, the Agency does not intend to exempt this proposed class II 
device from premarket notification (section 510(k) of the FD&C Act) 
submission as provided for under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering the information from the reports and 
recommendations of the Panel for the classification of these devices, 
along with information in the petition submitted under section 513(e) 
of the FD&C Act and any additional information that FDA has at its 
disposal, FDA has identified and evaluated the risks to health 
associated with the use of stair-climbing wheelchairs. The petition 
dated October 22, 2012 (Ref. 1), identified risks to health for all 
stair-climbing wheelchairs; FDA found these risks to be applicable and 
identified additional risks to health that apply to stair-climbing 
wheelchair devices:
     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.

[[Page 35176]]

     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.
     Falls/Fractures: The device is physically heavy and if 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.
     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: Pressure sores or 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.

VI. Summary of Reasons for Reclassification

    If properly manufactured and used, FDA believes that these devices 
can be utilized to provide mobility over a variety of terrains and 
obstacles encountered in everyday life, specifically climbing stairs. 
Many of these environments would not be accessible and many tasks could 
not be completed without the availability of a stair-climbing 
wheelchair. FDA believes that stair-climbing wheelchairs should be 
reclassified from class III to class II because special controls, in 
addition to general controls, can be established to provide reasonable 
assurance of the safety and effectiveness of the devices, and because 
general controls themselves are insufficient to provide reasonable 
assurance of its safety and effectiveness. In addition, there is now 
adequate information sufficient to establish special controls to 
provide such assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of these devices. Therefore, in accordance 
with section 513(e) of the FD&C Act and Sec.  860.130, based on new 
information with respect to the device, FDA, in response to the 
petition dated October 22, 2012, and submitted under section 513(e), is 
proposing to reclassify this preamendments class III device into class 
II. Since the time of the original panel recommendation and device 
classification, sufficient evidence has been developed to support a 
reclassification of stair-climbing wheelchairs from class III to class 
II with special controls. The petitioner cites the petitioner's own 
history of use, the petitioner's own preclinical testing, and the 
development of relevant consensus standards that provide sufficient 
evidence that stair-climbing wheelchairs can be effective for providing 
mobility over a variety of terrains and obstacles that are encountered 
in everyday life. Specifically, the petitioner notes that these devices 
need to comply with the following consensus standards:
     ``American National Standards Institute (ANSI)/
Rehabilitative Engineering & Assistive Technology Society (RESNA) 
American National Standard for Wheelchairs--Volume 1: Requirements and 
Test Methods for Wheelchairs (including Scooters),'' sections 1, 5, 7, 
8, 11, 13, 15, 16, 22, and 26. These are consensus standards applicable 
to both powered and mechanical wheelchairs to ensure proper performance 
regarding static stability, endurance/fatigue testing, and flammability 
as well as characterization of measurements and dimensions.
     ``ANSI/RESNA American National Standard for Wheelchairs--
Volume 2: Additional Requirements for Wheelchairs (including Scooters) 
with Electrical Systems,'' sections 2, 3, 4, 6, 9, 10, 14, and 21. 
These are consensus standards applicable to powered wheelchairs to 
ensure proper performance regarding dynamic stability, brake 
effectiveness, curb climbing ability, electrical safety testing and 
electromagnetic compatibility testing as well as characterization of 
speed/acceleration, battery longevity, and environmental testing.
     ``International Standards Organization (ISO) 7176 
Wheelchairs,'' parts 1 to 6, 9 to 11, 13 to 16, and 21. These consensus 
standards address the same testing and attributes noted in the 
previously noted volumes of the ANSI/RESNA standards.
    FDA believes that this information constitutes sufficient evidence 
to demonstrate that the proposed special controls can effectively 
mitigate the risks to health identified in section V of this document, 
and that these special controls in addition to the general controls 
will provide a reasonable assurance of safety and effectiveness for 
stair-climbing wheelchairs.

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with 
general controls (including applicable prescription-use restrictions), 
are sufficient to mitigate the risks to health described in section V 
of this document:
     The design characteristics of the device must ensure that 
the geometry and material composition are consistent with the intended 
use.
     Performance testing must demonstrate adequate mechanical 
performance under simulated use conditions and environments. 
Performance testing must include the following:
    [cir] Fatigue testing;
    [cir] Endurance testing;
    [cir] Resistance to dynamic loads (impact testing);
    [cir] Effective use of the braking mechanism and how the device 
stops in case of an electrical brake failure;
    [cir] Demonstration of adequate stability of the device on inclined 
planes (forward, backward, and lateral);
    [cir] Demonstration of the ability of the device to safely ascend 
and descend obstacles (e.g., stairs, curb); and
    [cir] Demonstration of ability to effectively use the device during 
adverse temperatures and following storage in adverse temperatures and 
humidity conditions.
     The skin-contacting components of the device must be 
demonstrated to be biocompatible.
     Software design, verification, and validation must 
demonstrate that the device controls, alarms, and user interfaces 
function as intended.
     Appropriate analysis and performance testing must be 
conducted to verify electrical safety and electromagnetic compatibility 
of the device.
     Performance testing must demonstrate battery safety and 
evaluate longevity.
     Performance testing must evaluate the flammability of 
device components.
     Patient labeling must bear all information required for 
the safe and

[[Page 35177]]

effective use of the device, specifically including the following:
    [cir] A clear description of the technological features of the 
device and the principles of how the device works;
    [cir] A clear description of the appropriate use environments/
conditions, including prohibited environments;
    [cir] Preventive maintenance recommendations;
    [cir] Operating specifications for proper use of the device such as 
patient weight limitations, device width, and clearance for 
maneuverability; and
    [cir] A detailed summary of the device-related adverse events and 
how to report any complications.
     Clinician labeling must include all the information in the 
patient labeling noted previously but must also include the following:
    [cir] Identification of patients who can effectively operate the 
device; and
    [cir] Instructions how to fit, modify, or calibrate the device.
     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.
    Stair-climbing wheelchairs are prescription devices restricted to 
patient use only upon the authorization of a practitioner licensed by 
law to administer or use the device. (Proposed Sec.  890.3890(a) (21 
CFR 870.3890(a)); see section 520(e) of the FD&C Act and 21 CFR 801.109 
(Prescription devices)). Prescription-use requirements are a type of 
general control authorized under section 520(e) of the FD&C Act and 
defined as a general control in section 513(a)(1)(A)(i) of the FD&C 
Act; and under Sec.  807.81, the device would continue to be subject to 
510(k) notification requirements.

IX. 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.

X. Paperwork Reduction Act of 1995

    This proposed 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; 
the collections of information in 21 CFR part 814, subpart B, have been 
approved under OMB control number 0910-0231; and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

XI. References

    The following reference has 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 is 
available electronically at http://www.regulations.gov.

    1. Petition from Deka Research & Development Corp., October 22, 
2013 (Docket No. FDA-2012-P-1155).

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order 
become effective on the date of its publication in the Federal Register 
or at a later date if stated in the final order.

XIII. Comments

    Interested persons may submit either electronic comments regarding 
this document or the associated petition to http://www.regulations.gov 
or written comments to the Division of Dockets Management (see 
ADDRESSES). It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at http://www.regulations.gov.

XIV. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) 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), as amended by FDASIA, in this 
proposed order, we are proposing to revoke the requirements in Sec.  
890.3890 related to the classification of stair-climbing wheelchairs as 
class III devices and to codify the reclassification of stair-climbing 
wheelchairs into class II.

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, it is 
proposed that 21 CFR part 890 be 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 and is intended to climb 
stairs while the patient remains in the chair. Characteristics of the 
device enabling this capability may include two endless belt tracks 
that adjust to the angle of the stairs. This may also include a 
balancing mechanism to steady the chair as it ascends/descends the 
staircase.
    (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;
    (ii) Endurance testing;
    (iii) Resistance to dynamic loads (impact testing);
    (iv) Effective use of the braking mechanism and how the device 
stops in case of an electrical brake failure;
    (v) Demonstration of adequate stability of the device on inclined 
planes (forward, backward and lateral);
    (vi) Demonstration of the ability of the device to safely ascend 
and descend obstacles (e.g., stairs, curb); and
    (vii) Demonstration of ability to effectively use the device during 
adverse temperatures and following storage in adverse temperatures and 
humidity conditions.

[[Page 35178]]

    (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 noted 
previously in the patient labeling but must also include the following:
    (i) Identification of patients who can effectively operate the 
device; and
    (ii) Instructions 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: June 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13864 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P