Guidance for Industry and Food and Drug Administration Staff; Premarket Assessment of Pediatric Medical Devices; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Premarket Assessment of Pediatric Medical Devices." This guidance presents FDA's current thinking on the type of safety and effectiveness information needed to support marketing of pediatric devices and on measures to be used to help protect this vulnerable patient population during the course of clinical trials involving such products.