Zdrowie i gospodarka · 01/06/2012

Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered patient transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility impaired person up and down flights of stairs. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).