Title :
Development of PMA guidance for ventricular assist devices and total artificial heart
Author_Institution :
Food & Drug Adm., Silver Spring, MD, USA
fDate :
6/1/1988 12:00:00 AM
Abstract :
The US Food and Drug Administration´s (FDA´s) involvement in the investigation of devices since 1980 is discussed. The development of draft guidelines for a premarket approval application (PMA) is described. The availability of the document is announced and comments are solicited.<>
Keywords :
artificial organs; cardiology; US Food and Drug Administration; premarket approval application; total artificial heart; ventricular assist devices; Animals; Artificial heart; Cardiology; Clinical trials; Drugs; Laboratories; Manufacturing; Materials testing; Safety devices; Surgery;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
