The U.S. Food and Drug Administration (FDA) recently released a Funding Opportunity Announcement (FOA) to facilitate the development, production, and distribution of pediatric medical devices through the funding of nonprofit consortia. The FOA includes efforts to leverage real-world evidence for regulatory evaluation of medical devices that will foster collaboration between NESTcc and external stakeholders to help advance innovation in the pediatric device space.
As part of the FOA, applicants are encouraged to submit real-world evidence (RWE) demonstration project proposals in the pediatric device space. Those applicants who are selected for funding to serve as nonprofit consortia will work collaboratively with NESTcc. For applicants choosing to propose RWE Demonstration Project(s), the proposal should include how the consortium will work directly with NESTcc to achieve the outlined goals.
To help applicants familiarize themselves with NESTcc priorities and current activities, NESTcc suggests that applicants review the following information:
- NESTcc’s overall Strategic and Operational Plan
- A recent webinar highlighting the capabilities of NESTcc data network collaborators
- The NESTcc Governing Committee
- Current NESTcc opportunities
- Designated NESTcc demonstration projects
Please direct any questions regarding the Funding Opportunity Announcement (FOA) to the FDA contacts listed in the Funding Opportunity Announcement for Pediatric Device Consortia Grants Program – 2018 (P50 Specialized Center).