The Office of Orphan Products Development (OOPD) is pleased to announce the recipients of the Pediatric Device Consortia (PDC) Grants Program Awards for 2018. The recipients for 2018 are:
- Medical Device Consortium at the Children’s Hospital of Philadelphia, Matthew Maltese, Ph.D.
- National Capital Consortium for Pediatric Device Innovation 2.0, Kolaleh Eskandanian, Ph.D., MBA
- Southwest National Pediatric Device Consortium, Chester Koh, M.D.
- Stanford Pediatric Device Consortium, Michael Harrison, M.D.
- West Coast Consortium for Technology and Innovation in Pediatrics, Juan Espinoza, M.D.
OOPD will fund up to $6,000,000, for fiscal year 2018 in support of this grants program including consortia advising and support services and projects to facilitate the development, production, and distribution of pediatric medical devices. Of the estimated $6 million this year, approximately $1 million will be used for the Real World Evidence (RWE) Demonstration Project, in which three of the consortia will conduct RWE projects in the pediatric space that develop, verify and operationalize methods of evidence generation, data use, and scalability across the health care systems, device types and manufacturers. The FDA intends to use the information gathered through this project to further efforts to incorporate RWE into the agency’s work. Future recommended support for four additional years will be contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
For more information about the funding opportunity announcement, review the 2018 Request For Application (RFA).