PubMed

医療機器の小児向けラベルにおける不一致を説明

PMID: 41343216 · 2025-12-01

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学術誌JAMA network open

年2025-12-01

PMID41343216

抄録

The US Food and Drug Administration (FDA) has recommended, but not required, age ranges for pediatric age labeling in devices, despite regulation existing for drugs, and this policy perpetuates off-label use of devices and creates several issues in practice for safety and monitoring. Proper device labeling is an important regulatory component that impacts risk stratification, clinical use, marketing, and reimbursement. To evaluate the variability in pediatric medical device age labeling among al

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