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# FDA Sends Congress FY 2024 Pediatric Device Approval Report
- URL: https://www.fdaweb.com/fda-sends-congress-fy-2024-pediatric-device-approval-report/
- Published: 2026-07-28T12:00:00.000Z
- Updated: 2026-09-14T13:43:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161529

FDA has just submitted the mandated FY 2024 report to Congress on the premarket approval of pediatric uses of medical devices. It is the 13th such report FDA has sent Congress as required by the Federal Food, Drug, and Cosmetic Act.

During FY 2024, the [report](https://www.fda.gov/media/193861/download?ref=fdaweb.com) says, the agency approved 56 premarket device applications. Specifically, it approved 53 original premarket approval (PMA) applications and panel-track supplements for devices, and three humanitarian device exemption (HDE) applications for devices. Of the 56, the agency says it approved 17 PMA applications and two HDE applications for devices that were indicated for use in a pediatric population or subpopulation. Of the remaining 37 device approvals, 36 PMA applications and one HDE application were for devices that were indicated for use solely in adults. Of the 37 device approvals, all were for devices that were determined to treat, diagnose, or cure a disease or condition for which there is a pediatric subpopulation that also suffers from the disease or condition.

FDA concludes there have been limited changes since the reports first were issued in 2008 in FDA’s PMA or HDE application approvals for devices intended for use in a pediatric population or subpopulation.