Describing Inconsistencies in Pediatric Labeling of Medical Devices.

Abstract

The US Food and Drug Administration (FDA) has recommended, but not required, age ranges for pediatric age labeling in devices, despite regulation existing for drugs, and this policy perpetuates off-label use of devices and creates several issues in practice for safety and monitoring. Proper device labeling is an important regulatory component that impacts risk stratification, clinical use, marketing, and reimbursement. To evaluate the variability in pediatric medical device age labeling among al