Improving the Infrastructure for Pediatric Medical Device Trials at Children's Hospitals.

Abstract

The shortage of novel pediatric devices that accommodate the unique needs of children exists due to several scientific, clinical, regulatory, and financial barriers. This global unmet need is being addressed in the United States by multiple stakeholders including the Food and Drug Administration (FDA) and its Pediatric Device Consortia (PDC) grant program. One critical area of interest is the suboptimal medical device clinical trial infrastructure that currently exists in academic medical center