title: Development of PMA guidance for ventricular assist devices and total artificial heart.
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.
authors.affiliation: Food and Drug Adm., Silver Spring, MD.
authors.forename: A
authors.initials: A
authors.lastname: Acharya