FDA Sponsors Pediatric Medical Device Submission Project

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and the Children’s National Hospital are inviting applications from manufacturers with already-cleared devices to use real world evidence (RWE) to gain FDA clearance for pediatric use.

The FDA-funded program will offer the devicemakers technical expertise, including access to mentors and design study protocols that use RWE methodologies, and will facilitate meetings between the device sponsors and FDA.

Pediatric use of medical devices “requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level,” the NCC-PDI says.

NCC-PDI has mentored over 160 medical device sponsors to help advance their pediatric innovations, with 12 devices having received either FDA market clearance or CE marking.