The reasoning behind pediatric medical device (PMD) development incentives does not support the use of incentives promoting device development for adults with rare conditions. While both of these directions are highly important, they function independently and do not affect each other. PMD development focuses on children, who differ in size, body chemistry, development, and disease propensity compared to adults (U.S. Food and Drug Administration [FDA], 2023).
Due to these aspects, the number of medical devices approved for pediatric use is minimal. Some of these devices are specifically designed for children, while others are modifications of adult applications (FDA, 2023). That is why the incentives for pediatric device development focus solely on devices for children. The FDA funds the Pediatric Device Consortia (PDC) grants to promote the development of PMDs.
Meanwhile, the incentives to stimulate device development for adults with rare conditions have little to do with pediatric devices. Rare diseases may develop in childhood, but many are diagnosed in adulthood, so devices and, correspondingly, incentives for these devices are different. The most popular incentive program for rare adult diseases is the Orphan Drug Designation program, which offers tax credits for clinical trials, potential exclusivity after approval, and exemption from user fees (FDA, 2022).
The only overlapping aspect between pediatric and adult rare disease device development is that if a person has had a rare disease since childhood, the device created by the pediatric incentive can be further adjusted for adult use. Both pediatric and rare disease devices face certain challenges in their development directions. At the same time, it is evident that both are vital in enhancing the quality of life for U.S. citizens, making their work particularly important. The FDA strives to provide incentives for crucial aspects of healthcare, as the health and well-being of citizens are the primary aims of society’s development.
References
U.S. Food and Drug Administration. (2022). Medical products for rare diseases and conditions.
U.S. Food and Drug Administration. (2023). Pediatric device consortia grants program.