[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0397]
Powered Wheelchair Labeling; Letter; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
