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. They’re focusing on leveraging real-world data. They will translate data into real-world evidence 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 include the MedStar Health Research Institute. There are also other Pediatric Device Consortia members. Other consortia members include the Center for Technology Innovation in Pediatrics (CTIP), the UCSF-Stanford Pediatric Device Consortium, the Pennsylvania Pediatric Device Consortium and the Southwest National Pediatric Device Consortium. The FDA is providing funding, with facilitation through NCC-PDI and the Office of Innovation Ventures at Children’s National.
Winning companies will receive technical expertise, including but not limited to regulatory, study design and data science services.
“We are delighted to partner with this coalition of trusted healthcare leaders that share our vision for advancing pediatric health. We know all too well that pediatric device development presents several unique challenges and that children have medical device needs that are considerably different from adults,” said Kolaleh Eskandanian, VP and chief innovation officer at Children’s National and principal investigator of NCC-PDI.
“There are already a number of medical devices on the market that have been FDA cleared or approved and proven viable, and this partnership will help provide important evidence generation and other wraparound services to guide device creators through the regulatory path for pediatric labeling,” Eskandanian said.
More about the pediatric devices initiative
As part of the collaboration, CobiCure is also seeking to support pediatric device labeling opportunities in the fields of interventional cardiology, cardiac surgery and associated critical care needs. The support may include funding, regulatory and project management support for specific projects that fit with CobiCure’s mission.
“We are thrilled to work with Kolaleh and the NCC-PDI on this important initiative. Using real-world data to support pediatric labeling fits with our mission to support the availability of medical technologies that are critical to the care of pediatric patient populations,” said Mark Veich, president of Advancium Health Network and executive director of the Deerfield Foundation.
The coalition has assembled a panel of judges specializing in data science, medical device development, evidence generation, post-market surveillance and the FDA’s regulatory pathway. The judges will review proposals from companies seeking pediatric labeling for their medical devices. Children’s National will provide companies selected through the RFP process with technical expertise.
NCC-PDI has mentored 250 medical device projects to help advance their pediatric innovations throughout all stages of the product life cycle.