Letters

Neurosurgery Urges Funding for Pediatric Device Consortia Grant Program

  • Drugs and Devices
  • 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 2024, 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 2024. 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.

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