Scientific Publications by FDA Staff

Pediatrics 2013 May;131(5):981-5

FDA's Pediatric Device Consortia: National Program Fosters Pediatric Medical Device Development.

Ulrich LC, Joseph FD, Lewis DY, Koenig RL

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. This statute called for the creation of nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices. RESULTS:A summary of the accomplishments of the pediatric device consortia is presented. Eleven million dollars have been awarded to 5 consortia since 2009. As of July 2012, they have collectively assisted in the development of 219 pediatric device ideas. The consortia provide innovators with both mentorship and services to help advance proposed pediatric device projects, including assistance with prototyping, identification of potential funding sources, preclinical and clinical trial design, and introductions to potential manufacturers. CONCLUSIONS:Currently, 5 federally funded pediatric device consortia exist to help advance the development of potential pediatric devices. These consortia serve as a national resource for those with ideas for medical devices that may advance the health and well-being of children.