Experience With Pediatric Medical Device Development

Abstract

Few FDA approved medical devices are specifically designed for children's needs. FDA approval for clinical indications of medical devices specify procedures and not patient ages. Accordingly, the majority of both devices and drugs in pediatric patients are used for off-label indications. Data suggests that 60-75% of medical devices or drugs in pediatric patients are used for off label indications (1). This approach has drawbacks including safety and performance concerns with lack of proper education and instructions for the use of an adult device for a pediatric patient.

Topics & Concepts