[Federal Register Volume 60, Number 120 (Thursday, June 22, 1995)]
[Notices]
[Pages 32528-32529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15347]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0397]


Powered Wheelchair Labeling; Letter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a letter concerning the labeling of powered 
wheelchairs. This letter, which was sent to all powered wheelchair, 
scooter, and accessory and component manufacturers, describes the 
agency's increasing concern about electromagnetic interference (EMI) 
with powered wheelchairs and motorized scooters (hereinafter 
collectively called powered wheelchairs). FDA believes that 
electromagnetic (EM) energy is causing these devices to move 
unintentionally. This letter is intended to establish certain necessary 
steps that powered wheelchair manufacturers should follow in order to 
help minimize the risks associated with the unintended movement of 
powered wheelchairs caused by EMI. FDA is publishing this notice 
because it believes that the letter may not have reached all interested 
persons.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the letter to 
the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-6597 or 1-800-638-2041. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests. Submit written comments on the letter to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should 
be identified with the docket number found in brackets in the heading 
of this document. The letter and received comments are available for 
public examination in the Dockets Management Branch (address above) 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Marie A. Schroeder, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1296.

SUPPLEMENTARY INFORMATION: On May 26, 1994, FDA issued a letter to all 
powered wheelchair, scooter, accessory, and component manufacturers 
explaining FDA's increasing concern about the effects of EMI on the 
safe use of powered wheelchairs. FDA has received many reports of 
erratic and unintentional powered wheelchair movement. The agency 
believes that EM energy is causing these devices to move 
unintentionally. As a result of these concerns, FDA established the 
following steps in order to provide information to protect powered 
wheelchair users from the potential hazards of EMI.

I. Minimum Recommended Immunity Level

    FDA recommends that all marketed powered wheelchairs have a minimum 
immunity level of 20 volts per meter (V/m). This immunity level was 
proposed by wheelchair manufacturers at the American National Standards 
Institute/Association for the Advancement of Rehabilitation Technology 
meeting in June 1993, and it reflects the present technological 
capability that can be immediately implemented.

II. Product Labeling

    The labeling described in FDA's letter is intended to inform 
powered wheelchair users about the risks from EMI associated with the 
use of powered wheelchairs and how to avoid these risks. This labeling 
should be on or attached to the powered wheelchair and provide the 
following information:
    1. An explanation of what EMI is, what causes EMI, and the risks 
associated with EMI;
    2. An explanation of how the user can avoid risks associated with 
EMI, including warnings to use caution around sources of EMI;
    3. A Warning that the addition of accessories or components, or 
modifications to a powered wheelchair may make it more susceptible to 
EMI, and that there is no easy way to evaluate their effect on the 
overall immunity of the powered wheelchair;
    4. A statement that, as of May 1994, 20 V/m is a generally 
achievable and useful immunity level; and
    5. A statement of the EMI immunity level of the powered wheelchair, 
or a statement that the EMI immunity level is not known.
    FDA believes that this information will help minimize the risks 
associated with unintended movement of powered wheelchairs caused by 
EMI. Omission of the labeling information requested above will result 
in a failure of the powered wheelchair labeling to include facts 
relevant to the powered wheelchair's use and in a failure to provide 
adequate warnings, as required by section 502 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 352). Accordingly, products 
shipped without the required labeling may be considered misbranded 
under section 502 of the act.

III. Recommended Educational Program

    FDA recommends that manufacturers implement an educational program 
to warn users of the potential hazards of EMI and to provide 
information about the risks and how to avoid them.
    Additionally, FDA will continue to solicit reports of EMI problems 
and to monitor the problems in order to evaluate the full scope of the 
problem.
    Interested persons may, at any time, submit to the Docket 
Management Branch (address above) written comments on the powered 
wheelchair labeling letter. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. The letter and received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether future 
action should be taken to address concerns about the effects of EMI on 
powered wheelchairs.

    [[Page 32529]] Dated: June 12, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-15347 Filed 6-21-95; 8:45 am]
BILLING CODE 4160-01-F