§360e–1 Pediatric Uses of Devices

Summary

Anyone sending an application under section 360j(m) or an application, supplement, or product development plan under section 360e must include, if readily available, a simple description of any groups of children who have the disease or condition the device is for and how many pediatric patients are affected. Within 18 months after September 27, 2007, and every year after that, the Secretary must send a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The report must show counts and review information for devices tied to pediatric groups (including devices used in children but not labeled for them where labeling could help), devices with humanitarian exemptions under 360j(m), devices labeled for children, devices fee-exempt under section 379j(a)(2)(B)(v), the review times for these groups, and how often adult data or one pediatric subgroup’s data were used to support use in other pediatric groups. The report must break these numbers down by pediatric subgroup. If the disease and the device work the same way in adults and children, the Secretary may use adult data to show the device works in children. A separate study is not always needed for each pediatric subgroup if data from one group can be applied to another. The term “pediatric subpopulation” is defined in section 360j(m)(6)(E)(ii).