Legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit consortia to help stimulate projects to promote the development and availability of pediatric medical devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012 and again in the FDA Reauthorization Act of 2017 to run through fiscal year 2022.
The PDC Grants Program was launched in 2009, and this is the fourth time the FDA has awarded grants. Each group’s grant runs for five consecutive years. Funding for fiscal year 2018 is approximately $1 million to $1.35 million per consortium. Support for the four additional years will be contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
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The consortia have assisted or advised more than 1,000 medical device projects since the program began. There are now 19 pediatric medical devices available to patients as a result of this grants program, including a needle-free blood collection device that attaches to peripheral IV systems for use as a direct blood draw device; a surgical vessel sealing system for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles and a rapid infusion device that delivers fluids to a patient’s vascular system.
“The consortia support a mix of projects at all stages of development and bring together individuals and institutions whose expertise and collaboration is essential to furthering our goal of bringing more pediatric medical devices to patients,” said Debra Lewis, O.D., acting director of the FDA’s Office of Orphan Products Development. “Each of the consortia will coordinate projects with the FDA, medical 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.”Back to HCB News