Zdrowie i gospodarka · 1.06.2012
Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a disabled person to move a wheelchair from one level to another. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).