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FDA Awards Grants to 5 Pediatric Medical Device Consortiums

October 11, 2018
The agency will advise and assist the grant recipients to advance their development.

A PPM Brief

FDA announced1 the awarding of five grants totaling up to $6 million a year over five years to the nationwide Pediatric Device Consortia (PDC). The consortia will provide advice and support services to innovators of children's medical devices, including advising on intellectual property, prototyping, engineering, laboratory and animal testing, grant-writing and clinical trial design.

“We know that developing products specifically for pediatric patients can present unique challenges to device developers and there are still many unmet needs for children with serious, debilitating or rare diseases,” said FDA Commissioner Scott Gottlieb, MD. “Our Pediatric Device Consortia Grant Program is one of a number of initiatives underway to foster the development and approval of safe and effective pediatric-specific medical devices.”

The Pediatric Device Consortia has assisted or advised more than 1,000 medical device projects since the program began in 2009. The Pediatric Device Consortia has assisted or advised more than 1,000 medical device projects since the program began in 2009. (Source: 123RF)

The PDC grant recipients for 2018 include:

  • Philadelphia Pediatric Medical Device Consortium
  • National Capital Consortium for Pediatric Device Innovation 2.0
  • Southwest National Pediatric Device Consortium
  • University of California San Francisco-Stanford Pediatric Device Consortium
  • West Coast Consortium for Technology and Innovation in Pediatrics

Approximately $1 million of the grant provided this year 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.

“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,” said Debra Lewis, OD, acting director of FDA’s Office of Orphan Products Development.

This will be the fourth time the FDA has awarded grants through the PDC Grants Program, originally launched in 2009. The consortia has assisted or advised more than 1,000 medical device projects since its inception, and there are now 19 pediatric medical devices available to patients as a result of the program. Devices include 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.

Last updated on: November 15, 2018
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