US FDA approval of pediatric artificial intelligence and machine learning–enabled medical devices

US FDA approval of pediatric artificial intelligence and machine learning–enabled medical devices
JAMA Pediatrics; Ryan C. L. Brewster, MD; Matthew Nagy, MD, MPH; Susmitha Wunnava, PhD; Florence T. Bourgeois, MD, MPH; 12/24
Despite rapid growth in the availability of AI/ML [artificial intelligence and machine learning]-enabled devices in recent years, only a small number have been authorized for pediatric use. The current regulatory framework may expose children to off-label use, differential performance of algorithms, and safety risks. Additionally, the lack of standardized reporting of pediatric device characteristics precludes informed decision-making by health care clinicians on appropriate device use. Pediatric AI/ML-enabled devices should be validated using representative datasets and should include complete and standard documentation on pediatric testing and authorization. Such changes will require cooperation across regulatory and industry stakeholders with a commitment to safe, equitable, and effective AI/ML development for children.