Zdrowie i gospodarka · 25/03/2013

FDA Proposes New Requirements for Automated External Defibrillator Systems

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for Automated External Defibrillator (AED) systems, which includes the device and its accessories, in an effort to reduce the risk of illness or injury and to eliminate or reduce the degree of risk.