Share of approvals carrying any pediatric indication, by pathway, against the 21.7% under-18 share of the US population.
Sources. Drugs: JAMA Pediatrics analysis of 553 new drugs and 918 indications, 2011–2023 (25.2% with pediatric labeling; 18.7% of nonorphan indications). PMA/HDE devices: FDA Report to Congress on Premarket Approval of Pediatric Uses of Devices, FY2008–FY2023 unweighted annual average (29% with any pediatric indication). AI/ML-enabled SaMD: JAMA Network Open 2024 cross-sectional analysis of 876 FDA-authorized AI/ML devices, 1995–March 2024 (~17% with pediatric labels). Population reference: US Census ACS 2024 (under-18 share, 21.7%). Caveat. The 25% drug figure includes any indication touching pediatrics, often through PREA extrapolation from adult studies. The 29% PMA average masks the fact that many pediatric labels apply to 18-to-21-year-olds; CDRH leadership has publicly indicated that fewer than 10% of approvals over the past decade are genuinely under-18 indicated.