USA – CDRH Drafts New Framework to Create a Pediatric Device Safety Network

A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus.

The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medical centers “have the breadth and depth of expertise to be able to innovate in a safe manner.” Partnerships with these centers will seek to create incentives not just to develop pediatric medical devices, but also to consider pediatrics before adult populations.

“If we can actually support technology development that assists the complex needs of children, we will accelerate device development for all, » Peiris argued.

The framework is still in the preliminary stages—so much so that when it was mentioned at a session during RAPS’ 2018 Convergence last week, the presentation slide that laid out the current vision was intentionally blurred by Peiris. Yet the hope is that the framework will be “a bit closer to being ready for prime time” in up to a year from now, Peiris said.


Both internal and external partners are currently being engaged to then begin working out the details of the framework. This is because the process for creating the new nationwide network that can support innovation in pediatric device development, dubbed System of Hospitals for Innovation in Pediatrics (SHIP), will be very similar to the process started about three years ago for the National Evaluation System for health Technology (NEST), Peiris noted.