New initiative aims to get more medical devices labelled for children

The Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) recently announced the opening of a request for proposals to solicit companies that are interested in gaining pediatric labeling for medical devices.

The program aims to generate real-world evidence (RWE) needed to facilitate the pediatric regulatory pathway for U.S. market clearance. The deadline to apply to the program is Feb. 9, 2023.

This initiative brings together a coalition of leading healthcare and academic organizations that are focused on leveraging real-world data that can be translated into RWE to gain FDA clearance or approval for use with children.

The partnership with CobiCare will address the gap between devices labeled for adults and children. Additional coalition partners are MedStar Health Research Institute and all other Pediatric Device Consortia members, including the Center for Technology Innovation in Pediatrics (CT…

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