The U.S. Food and Drug Administration announced that it has awarded five grants totaling up to USD 6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices. The program aims to enhance the development, production and distribution of pediatric medical devices and has awarded USD 37 million to various consortia since 2009.
The PDC grant recipients and their principal investigators for 2018 are the following:
• Philadelphia Pediatric Medical Device Consortium, Matthew Maltese, Ph.D.
• National Capital Consortium for Pediatric Device Innovation 2.0, Kolaleh Eskandanian, Ph.D., M.B.A.
• Southwest National Pediatric Device Consortium, Chester Koh, M.D.
• University of California San Francisco-Stanford Pediatric Device Consortium, Michael Harrison, M.D.
• West Coast Consortium for Technology and Innovation in Pediatrics, Juan Espinoza, M.D.
Specific areas of expertise provided by the consortia to medical device innovators include advising on issues related to: intellectual property, prototyping, engineering, laboratory and animal testing, grant-writing and clinical trial design to help foster and guide the advancement of medical devices specifically for children.
Of the estimated USD 6 million granted this year, approximately USD 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 device types, manufacturers and the health care system. The FDA intends to use the information gathered through this initiative to further efforts to incorporate RWE into the agency’s work.
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 USD 1 million to USD 1.35 million per consortium. Support for the four additional years will be contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
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.
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