FDA's pediatric device consortia: national program fosters pediatric medical device development.

Objectives: This article reports on the progress made in addressing pediatric medical device needs through the establishment of the Pediatric Device Consortia Grant Program. Pediatric practitioners should be aware of both the imperative for well-studied devices for children and the existence of recently created resources to help foster the development of such products.

Methods: This article discusses some of the challenges associated with pediatric device development and describes the implementation of section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007.