Mechanical devices and US Food and Drug Administration (FDA) approval.

Long-term ventricular assist devices for adults have advanced far more than have suitable devices for neonates and infants. The difficulties of design and construction of miniaturized blood pumping systems and the high costs associated with developing, testing, and approval of such devices has been prohibitive. Still, there is an important clinical need for such devices as the availability of donor hearts for this age group has been especially limited. Recently, several pneumatic pulsatile pumps have been developed based on the adult experience, and the issues of regulatory approval are now assuming greater importance for these devices. This chapter reviews the current system for medical device classification and the approval processes in the United States and in Europe. This system is continually evolving, with dedicated and knowledgeable professionals charged with assuring the efficacy, safety, appropriate labeling, and continuing surveillance of approved devices. Pediatric cardiac surgeons involved in transplantation and assist devices need to be aware of the regulatory issues, and work with manufacturers and governmental agencies to make sure that successful devices are available as soon as possible for their patients.