Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport, 14015-14017 [2013-04897]

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 14015-14017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2011-P-0804]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Powered Patient Transport

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 powered patient transport devices commonly known as 
stairway chair lifts. These devices are used to assist in the transfer 
of a person with a mobility impairment caused by injury or other 
disease up and down flights of stairs. This order exempts stairway 
chair lifts, 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 
stairway chair lifts. All other devices classified under FDA's powered 
patient transport regulations, including attendant-operated portable 
stair-climbing chairs (which are different from wheelchairs) 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. The device may not be marketed until

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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 November 7, 2011, FDA received a petition requesting an 
exemption from premarket notification for powered patient transport 
devices commonly known as stairlifts. (See Docket No. FDA-2011-P-0804.) 
These devices are currently classified under Sec.  890.5150 (21 CFR 
890.5150), Powered patient transport. 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 19, 2012. This restarted the 
180-day clock under section 510(m)(2) of the FD&C Act. (See Class II 
510(k) Exemption Guidance, p. 3.)
    In the Federal Register of June 1, 2012 (77 FR 32642), 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 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 19, 2012, and the comment on 
the petition, FDA has determined that premarket notification is not 
necessary to assure the safety and effectiveness of stairway chair 
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 powered patient 
transport devices classified under Sec.  890.5150 identified as 
``powered patient stairway chair 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.  890.5150, such as attendant-operated portable stair-climbing 
chairs (which are different from wheelchairs), 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 chair in 
the event of a device failure; (2) appropriate analysis and nonclinical 
testing must demonstrate the ability of the device, including armrests, 
to withstand the rated load with an appropriate factor of safety; (3) 
appropriate restraints must be provided to prevent the user from 
falling from the device (such as that outlined in the currently FDA-
recognized edition of ASME A18.1 ``Safety Standard for Platform Lifts 
and Stairway Chair Lifts''); (4) appropriate analysis and nonclinical 
testing (such as that outlined in the currently FDA-

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recognized edition 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; and (5) appropriate analysis and nonclinical testing must 
demonstrate the resistance of the device upholstery to ignition.
    Firms are now exempt from 510(k) requirements for stairway chair 
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 890.5150 is revised to read as follows:


Sec.  890.5150  Powered patient transport.

    (a) Powered patient stairway chair lifts--(1) Identification. A 
powered patient stairway chair lift is a motorized lift equipped with a 
seat and permanently mounted in one location that is intended for use 
in mitigating mobility impairment caused by injury or other disease by 
moving a person up and down a stairway.
    (2) Classification. Class II. The stairway chair 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 American Society of 
Mechanical Engineers (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 chair in the event of a 
device failure;
    (ii) Appropriate analysis and nonclinical testing must demonstrate 
the ability of the device, including armrests, to withstand the rated 
load with an appropriate factor of safety;
    (iii) Appropriate restraints must be provided to prevent the user 
from falling from the device (such as that outlined in the currently 
FDA-recognized edition of ASME A18.1 ``Safety Standard for Platform 
Lifts and Stairway Chair Lifts'');
    (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; and
    (v) Appropriate analysis and nonclinical testing must demonstrate 
the resistance of the device upholstery to ignition.
    (b) All other powered patient transport--(1) Identification. A 
powered patient transport is a motorized device intended for use in 
mitigating mobility impairment caused by injury or other disease by 
moving a person from one location or level to another, such as up and 
down flights of stairs (e.g., attendant-operated portable stair-
climbing chairs). This generic type of device does not include 
motorized three-wheeled vehicles or wheelchairs.
    (2) Classification. Class II.

    Dated: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04897 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P