FDA Encourages Development of Pediatric Devices
FDA is providing seven grants to encourage the development of medical devices for children. FDA defines “pediatric devices” as those "used for patients who are 21 years of age or younger at the time of diagnosis or treatment."
Adding up to more than $3.5 million, the grants are being given by FDA’s Office of Orphan Products Development to the following recipients:
- James Geiger, M.D., University of Michigan Pediatric Device Consortium
- David Ku, M.D., Ph.D., Atlantic Pediatric Device Consortium
- Peter Kim, M.D., National Capital Consortium for Pediatric Device Innovation
- Rick Greenwald, Ph.D., New England Pediatric Device Consortium
- Yaniv Bar-Cohen, M.D., Southern California Center for Technology and Innovation in Pediatrics
- Matthew Maltese, M.S., Ph.D., Philadelphia Regional Pediatric Medical Device Consortium
- Pedro del Nido, M.D., Boston Pediatric Device Consortium
“These consortia are part of FDA’s commitment to medical product innovation in areas of unmet medical need and will support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization,” said Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development, on FDA's Web site. “At each stage, the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device projects.”
The agency reports that while the program is administered by the OOPD, it will apply to medical devices used in all pediatric diseases, not just rare diseases.
For more details, visit FDA's web site on the Pediatric Device Consortia (PDC) Grant Program.