Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

The Food and Drug Administration (FDA) aims to promote safe and effective device use in pediatric patients, while ensuring device approvals are based on valid scientific evidence.1 Currently, there is a paucity of scientific evidence available to substantiate submissions for devices that are indicated for use in the diagnosis or treatment of pediatric patients. Leveraging relevant available clinical data, when appropriate, may lead to more devices being granted marketing authorization for pediatric indications, which will increase the availability of medical devices with appropriate labeling to support safe and effective device use in pediatric patients. This approach will potentially streamline the process for establishing a pediatric intended use claim, and enhance and encourage pediatric device development programs.