FDA Loosens Controls on Stair-Climbing Wheelchairs

The Food and Drug Administration reclassifying stair-climbing wheelchairs as Class II devices that do not require premarket approval, in a final rule that takes effect April 14. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Stair-climbing wheelchairs will not be exempt from premarket notification requirements.