US FDA awards $3.5m in grants for pediatric medical device development
The US Food and Drug Administration has awarded seven grants totaling more than $3.5 million to various pediatric device companies to boost the development and availability of medical devices for children.
Children present unique challenges to device developers, as they differ in terms of size, growth and body chemistry. Funding for nonprofit consortia was established in 2007 when Congress passed medical device legislation to help stimulate projects to promote the development and availability of pediatric devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012.
“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. At each stage, the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device projects.”
Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development.
The grant recipients are:
• 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
The grants have been awarded by the FDA’s Office of Orphan Product Development, but are intended to encompass devices used in all pediatric diseases, not just rare diseases.
Each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.
Along the way, the consortia will work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations, and agency guidance to protect the health and safety of children.
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