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Analysis highlights longer review times and more clinical trials for pediatric medical devices, implying need for standardized age labeling.
In this study, pediatric devices were rare, emerged recently, and had longer review times and a higher proportion of registered clinical trials compared with nonpediatric devices, suggesting expectations for more pediatric-specific evidence despite unchanged statutory standards. To address gaps in pediatric device development, the FDA should standardize age labeling and validation requirements for AI-enabled technologies.
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Zapotoczny et al. (2026) studied this question.
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