Zdrowie i gospodarka · 07/01/2014

FDA Proposes Changes to Classification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps

The FDA is proposing to reclassify nonroller-type cardiopulmonary bypass blood pumps used for cardiopulmonary and circulatory bypass from Class III to Class II, requiring premarket notification and potentially premarket approval for temporary ventricular support, in an effort to reduce the risk of illness or injury associated with these devices.