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September 14, 2018

FDA funds paediatric medical devices development

The US Food and Drug Administration (FDA) has revealed plans to support the Pediatric Device Consortia (PDC) programme aimed at the development, production and distribution of paediatric medical devices.

The US Food and Drug Administration (FDA) has revealed plans to support the Pediatric Device Consortia (PDC) programme aimed at the development, production and distribution of paediatric medical devices.

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The regulatory authority awarded five grants totalling up to $6m a year over the next five years.

PDC recipients will use the grants to offer support, including advice on intellectual property, animal testing, prototyping and clinical trial design, to those creating medical devices for children.

“For the 2018 fiscal year, the funding is around $1m to $1.35m per consortium. Grants for the four additional years will be based on annual appropriations, funding availability and awardee performance.”

Of the total funds, $1m will be used for the Real World Evidence (RWE) Demonstration Project.

Three of the consortia will conduct RWE projects to develop, verify and operationalise approaches for the generation of evidence, data use and scalability across various device types, manufacturers and health care system.

FDA commissioner Scott Gottlieb said: “We know that developing products specifically for paediatric patients can present unique challenges to device developers and there are still many unmet needs for children with serious, debilitating or rare diseases.

“Our Pediatric Device Consortia Grant Program is one of a number of initiatives underway to foster the development and approval of safe and effective paediatric-specific medical devices.”

Launched in 2009, the PDC Grants Program has awarded a total of $37m to various consortia, which helped or advised more than 1,000 projects for medical devices.

For the 2018 fiscal year, the funding is around $1m to $1.35m per consortium. Grants for the four additional years will be based on annual appropriations, funding availability and awardee performance.

The programme has resulted in 19 paediatric medical devices so far, including a needle-free blood collection device, a surgical vessel sealing system and a rapid infusion device.

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