GAO Report on Pediatric Medical Devices
The Government Accountability Office (GAO) has issued a report entitled “Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting.” This report: (1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data on the number of pediatric devices approved since FDAAA was enacted. The GAO found that while FDA created an electronic flag in its internal tracking system to identify devices labeled for use in pediatric patients, FDA has not consistently used this flag and therefore lacks reliable and timely information needed for reporting. The GAO recommends that FDA collect reliable information to report data on pediatric medical devices by consistently using its existing pediatric electronic flag in its tracking system or otherwise developing internal controls. HHS concurred with GAO’s recommendations.
