- The Honorable Martin Heinrich
Chair
Agriculture, Rural Development, FDA, and
Related Agencies Subcommittee
United States Senate
Washington, DC 20510 - The Honorable John Hoeven
Ranking Member
Agriculture, Rural Development, FDA, and
Related Agencies Subcommittee
United States Senate
Washington, DC 20510 - The Honorable Andy Harris
Chair
Agriculture, Rural Development, FDA, and
Related Agencies Subcommittee
United States House of Representatives
Washington, DC 20515 - The Honorable Sanford Bishop, Jr.
Ranking Member
Agriculture, Rural Development, FDA, and
Related Agencies Subcommittee
United States House of Representatives
Washington, DC 20515
Dear Chair Heinrich, Chair Harris, Ranking Member Hoeven, and Ranking Member Bishop:
As you begin to consider funding priorities for Fiscal Year 2025, we urge you to fund the Pediatric Device Consortia (PDC) Grant Program at the Office of Orphan Products Development (OOPD) at the Food and Drug Administration (FDA) at $7 million in Fiscal Year 2025. To address the need for improved pediatric medical devices, Congress created the PDC Program and has renewed it since its inception in 2007. The PDC Program provides grants to non-profit pediatric medical device consortia, which assist scientists and innovators, particularly small businesses, with technical and financial resources to improve the number of medical devices available to children.
Medical devices for children often lag five to ten years behind those for adults. Pediatric populations pose significant challenges for device manufacturers as there are many factors that limit children’s access to safe and effective medical devices, including differences in size, weight, and metabolism rate. Often, a pediatric surgeon, pediatrician, or a scientist has an idea for a new or improved pediatric medical device. However, being unfamiliar with the process of developing and seeking approval for a medical device, they may not know where to start. The PDC funded through this competitive grant program help connect these individuals to the support networks and resources they need to navigate the sometimes complex and lengthy medical device approval process.
Since their inception in 2009, the PDC have been remarkably successful. The five geographically dispersed consortia assisted with 647 pediatric medical device products in the past year. Most of the devices supported by the consortia are in the early stages of development, including concept formation, prototyping, and preclinical (animal and bench testing) stages, however, 50 devices are now available to patients. As a direct result of their efforts in FY 2023, several devices have been cleared for use in children, including the Neoasis incubator-based active noise control ANNE One, and the Orchid Safety Release Valve.
Click here to read the full Neurosurgery Urges Congress to Fund Pediatric Device Consortia.
