Interpretation ID: 2838yy
Acting Director
Center for Devices and Radiological Health
Food and Drug Administration
12720 Twinbrook Parkway
Rockville, MD 20857
Dear Mr. Gundaker:
This responds to your December 26, 1990 letter concerning mechanical hand and foot driving controls. These controls are intended to enable persons who have limited use of their arms or legs to drive a motor vehicle. In your letter you stated that, because these controls raise questions regarding motor vehicle safety, your agency would like to revoke their present classification as a class II medical device. However, before you do this, you would "need assurances that these driving controls for handicapped persons do fall in the jurisdiction of NHTSA and that significant complaints of malfunction would be investigated by NHTSA." The following is a summary of our statutory authority in this area.
Section 103 of the National Traffic and Motor Vehicle Safety Act (the Safety Act; 15 U.S.C. 1392) authorizes NHTSA to issue Federal Motor Vehicle Safety Standards that set performance requirements for new motor vehicles and items of motor vehicle equipment. The driving controls that are the subject of your letter would be considered items of motor vehicle equipment, within the meaning of the Safety Act. However, this agency has not issued any standards setting forth performance requirements for controls for disabled drivers. Obviously, these controls could not be determined to be in noncompliance with a safety standard if there is no applicable safety standard.
Another possible source of authority for NHTSA would be 108(a)(2)(A) of the Safety Act (15 U.S.C. 1397(a)(2)(A)), which specifies that, "no manufacturer, distributor, dealer, or motor vehicle repair business shall knowingly render inoperative, in whole or part, any device or element of design installed on or in a motor vehicle or item of motor vehicle equipment in compliance with an applicable Federal motor vehicle safety standard." This statutory prohibition would be violated if a manufacturer, distributor, dealer, or repair business installed a mechanical hand or foot driving control so as to "render inoperative" any of the elements of design installed in the original vehicle in compliance with one of our safety standards. However, when NHTSA has been asked about this in the past, the agency has generally stated that it would not institute enforcement proceedings under section 108(a)(2)(A) of the Safety Act against dealers or repair shops when a particular vehicle must be modified to accommodate the needs of a particular disability.
Finally, the agency has authority to investigate allegations that items of motor vehicle equipment, such as these controls, contain defects related to motor vehicle safety, and to order the equipment manufacturer to notify owners and to remedy without charge any items of equipment determined to contain a defect related to motor vehicle safety, as provided in sections 151-160 of the Safety Act (15 U.S.C. 1411-1420). If there were indications that these controls contained a defect related to motor vehicle safety, the agency would investigate and take appropriate actions. Of course, as with any investigation of alleged safety-related defects, the outcome would depend on the facts of the specific investigation.
I hope you find this information helpful. If you have further questions or need some additional information in this area, please contact Mary Versailles of my staff at this address or by telephone at (202) 366-2992.
Sincerely,
Paul Jackson Rice Chief Counsel
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