Interpretation ID: nht90-4.97

TYPE: Interpretation-NHTSA

DATE: December 26, 1990

FROM: Walter E. Gundaker -- Acting Director, Center for Devices and Radiological Health, Department of Health & Human Services

TO: Paul Jackson Rice -- Chief Counsel, NHTSA

TITLE: None

ATTACHMT: Attached to letter dated 2-19-91 from Paul Jackson Rice to Walter E. Gundaker (A37; VSA 102(4); VSA 108(a)(2))

TEXT:

On November 23, 1983 the Food and Drug Administration published in the Federal Register a Final Rule classifying the mechanical automobile hand and foot driving control as a class II medical device. The product is intended to enable persons who have lim ited use of their arms or legs to drive an automobile. The device allows hand operation of the gas, brake, and clutch pedals or foot operation of the steering and gear shift.

Recently we have found that more sophisticated versions of the controls are being developed. These products, which incorporate a joy stick, a microprocessor and servo controls, permit individuals with very limited body control to drive a motor vehicle. Applications to FDA for approval to market these controls have raised questions about vehicle safety which we feel are more appropriately addressed by the National Highway Traffic Safety Administration (NHTSA).

In view of the nature of these products, we would like to revoke the classification of the mechanical hand and foot driving control, and not actively regulate the device. Before we do this, however, we need assurances that these driving controls for han dicapped persons do fall in the jurisdiction of NHTSA and that significant complaints of malfunction would be investigated by NHTSA. Could you give us such assurances?

Thank you for your consideration of this subject. If you or your staff need additional background or information, please contact Mr. Leighton Hansel in our Office of Compliance & Surveillance at (301) 427-1144.