Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator, 14013-14015 [2013-04899]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Rules and Regulations]
[Pages 14013-14015]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2011-P-0882]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Wheelchair Elevator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order 
granting a petition requesting exemption from premarket notification 
requirements for wheelchair elevator devices commonly known as inclined 
platform lifts and vertical platform lifts. These devices are used to 
provide a means for a person with a mobility impairment caused by 
injury or other disease to move from one level to another, usually in a 
wheelchair. This order exempts wheelchair elevators, class II devices, 
from premarket notification and establishes conditions for exemption 
for this device that will provide a reasonable assurance of the safety 
and effectiveness of the device without submission of a premarket 
notification (510(k)). This exemption from 510(k), subject to these 
conditions, is immediately in effect for wheelchair elevators. All 
other devices classified under FDA's wheelchair elevator regulations, 
including attendant-operated stair climbing devices for wheelchairs and 
portable platform lifts, continue to require submission of 510(k)s. FDA 
is publishing this order in accordance with the section of the Food, 
Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a 
device from the requirement to submit a 510(k).

DATES: This order is effective March 4, 2013.

FOR FURTHER INFORMATION CONTACT: Brian Pullin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1554, Silver Spring, MD 20993, 301-796-6455.

SUPPLEMENTARY INFORMATION: 

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its 
implementing regulations (21 CFR part 807) require persons who propose 
to begin the introduction or delivery for introduction into interstate 
commerce for commercial distribution of a device intended for human use 
to submit a 510(k) to FDA.

[[Page 14014]]

The device may not be marketed until FDA finds it ``substantially 
equivalent'' within the meaning of section 513(i) of the FD&C Act (21 
U.S.C. 360c(i)) to a legally marketed device that does not require 
premarket approval.
    On November 21, 1997, the President signed into law the Food and 
Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115), section 206 of which added section 510(m) to the FD&C Act. 
Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after 
enactment of FDAMA, to publish in the Federal Register a list of each 
type of class II device that does not require a report under section 
510(k) of the FD&C Act to provide reasonable assurance of safety and 
effectiveness. Section 510(m) of the FD&C Act further provides that a 
510(k) will no longer be required for these devices upon the date of 
publication of the list in the Federal Register. FDA published that 
list in the Federal Register of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a 
device from premarket notification requirements on its own initiative, 
or upon petition of an interested person, if FDA determines that a 
510(k) is not necessary to provide reasonable assurance of the safety 
and effectiveness of the device. This section requires FDA to publish 
in the Federal Register a notice of intent to exempt a device, or of 
the petition, and to provide a 30-day comment period. FDA must publish 
in the Federal Register its final determination regarding the exemption 
of the device that was the subject of the notice. If FDA fails to 
respond to a petition under this section within 180 days of receiving 
it, the petition shall be deemed granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
guidance that the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions From Premarket 
Notification, Guidance for Industry and CDRH Staff '' (Class II 510(k) 
Exemption Guidance). That guidance can be obtained through the Internet 
on the Center for Devices and Radiological Health home page at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 159 to identify the guidance you are requesting.

III. Petition

    On December 2, 2011, FDA received a petition requesting an 
exemption from premarket notification for a wheelchair elevator 
commonly known as an inclined platform lift and a vertical platform 
lift. (See Docket No. FDA-2011-P-0882.) These devices are currently 
classified under 21 CFR 890.3930, Wheelchair elevator. On May 3, 2012, 
FDA responded to the petition with a letter explaining that the 
information provided in the petition was insufficient for the Agency to 
assess whether the risks posed by this type of device could be 
sufficiently mitigated in the absence of premarket notification 
requirements. To address the Agency's concerns, the petitioner 
submitted additional information regarding standards that could be 
relied upon to mitigate the device risks, which the Agency received on 
June 7, 2012. This restarted the 180-day clock under section 510(m)(2) 
of the FD&C Act. (See Class II Exemption Guidance, p. 3.)
    In the Federal Register of June 1, 2012 (77 FR 32644), FDA 
published a notice announcing that this petition had been received and 
provided opportunity for interested persons to submit comments on the 
petition by July 2, 2012. FDA received one comment supporting an 
exemption from premarket notification for this type of device. The 
comment stated that these devices have been produced for many years and 
have a very good safety record. It noted that all of these products 
already need to comply with the FDA-recognized American Society of 
Mechanical Engineers (ASME) standard ``ASME A18.1 Safety Standard for 
Platform Lifts and Stairway Chairlifts'' (ASME A18.1), which provides 
that these products are to be built and certified to the provisions of 
the National Electric Code and the Canadian Standards Association 
(CSA)/ASME standard ``CSA B44.1/ASME A17.5 Elevator and Escalator 
Electrical Equipment'' for elevator and escalator electrical equipment.
    FDA has assessed the need for 510(k) clearance for this type of 
device against the criteria laid out in the Class II 510(k) Exemption 
Guidance and in 63 FR 3142, and agrees they weigh in favor of 510(k) 
exemption, as long as certain conditions are met. FDA agrees that the 
risks posed by the device and the characteristics of the device 
necessary for its safe and effective performance are well established. 
FDA believes that changes in the device that could affect safety and 
effectiveness will be readily detectable by certain types of routine 
analysis and nonclinical testing, such as those detailed in certain 
consensus standards. Therefore, after reviewing the petition, the 
additional information received on June 7, 2012, and the comment on the 
petition, FDA has determined that premarket notification is not 
necessary to assure the safety and effectiveness of inclined and 
vertical platform lifts, as long as the conditions for 510(k) exemption 
listed in this document are met. FDA responded to the petition by 
letter dated December 3, 2012, to inform the petitioner of this 
decision within the 180-day timeframe under section 510(m)(2) of the 
FD&C Act.
    For clarity, this order: (1) Defines a subset of wheelchair 
elevators classified under Sec.  890.3930 identified as ``permanently 
mounted wheelchair platform lifts'' and (2) exempts this subset of 
devices from premarket notification requirements provided certain 
conditions are met, which will be codified in this classification 
regulation. This order does not affect other devices classified under 
Sec.  890.3930, such as attendant-operated stair climbing devices for 
wheelchairs and portable platform lifts, which remain subject to 
premarket notification requirements, and does not change the class of 
any of the devices classified under this regulation, which all remain 
in class II. These devices will remain subject to current good 
manufacturing practices requirements and other general controls under 
the statute.

IV. Conditions for Exemption

    This final order provides conditions for exemption from premarket 
notification on appropriate testing and labeling of the device. The 
following conditions must be met for the device to be 510(k)-exempt: 
(1) Appropriate analysis and nonclinical testing (such as that outlined 
in the currently FDA-recognized edition of ASME A18.1 ``Safety Standard 
for Platform Lifts and Stairway Chair Lifts'') must demonstrate that 
the safety controls are adequate to prevent a free fall of the platform 
in the event of a device failure; (2) appropriate analysis and 
nonclinical testing must demonstrate the ability of the device to 
withstand the rated load with an appropriate factor of safety; (3) 
appropriate analysis and nonclinical testing must demonstrate the 
ability of the enclosures to prevent the user from falling from the 
device; and (4) appropriate analysis and nonclinical testing (such as 
that outlined in the currently FDA-recognized edition of AAMI/ANSI/IEC 
60601-1-2, ``Medical

[[Page 14015]]

Electrical Equipment--Part 1-2: General Requirements for Safety--
Collateral Standard: Electromagnetic Compatibility--Requirements and 
Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and 
Stairway Chair Lifts'') must validate electromagnetic compatibility and 
electrical safety.
    Firms are now exempt from 510(k) requirements for vertical and 
inclined platform lifts as long as they meet these conditions of 
exemption. Firms must comply with the particular mitigation measures 
set forth in the conditions for exemption or submit and receive 
clearance for a 510(k) prior to marketing.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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 contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

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 890.3930 is revised to read as follows:


Sec.  890.3930  Wheelchair elevator.

    (a) Permanently mounted wheelchair platform lift--(1) 
Identification. A permanently mounted wheelchair platform lift is a 
motorized vertical or inclined platform lift device permanently 
installed in one location that is intended for use in mitigating 
mobility impairment caused by injury or other disease by providing a 
guided platform to move a person from one level to another, with or 
without a wheelchair.
    (2) Classification. Class II. The permanently mounted wheelchair 
platform lift is exempt from premarket notification procedures in 
subpart E of part 807 of this chapter, subject to Sec.  890.9 and the 
following conditions for exemption:
    (i) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must 
demonstrate that the safety controls are adequate to prevent a free 
fall of the platform in the event of a device failure;
    (ii) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must 
demonstrate the ability of the device to withstand the rated load with 
an appropriate factor of safety;
    (iii) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must 
demonstrate the ability of the enclosures to prevent the user from 
falling from the device; and
    (iv) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 
60601-1-2, ``Medical Electrical Equipment--Part 1-2: General 
Requirements for Safety--Collateral Standard: Electromagnetic 
Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must validate 
electromagnetic compatibility and electrical safety.
    (b) Portable wheelchair elevators--(1) Identification. A portable 
wheelchair elevator is a motorized lift device that is not permanently 
mounted in one location and that is intended for use in mitigating 
mobility impairment caused by injury or other disease by providing a 
means to move a person, with or without a wheelchair, from one level to 
another (e.g., portable platform lifts, attendant-operated stair 
climbing devices for wheelchairs).
    (2) Classification. Class II.

    Dated: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04899 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P