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Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities.

PMID: 35425971 · 2022-05-01

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ZeitschriftPediatrics

Jahr2022-05-01

PMID35425971

Zusammenfassung

Few medical devices are designed and marketed specifically for children. Instead, adult devices are often repurposed and used off-label in pediatrics. The innovation gap between pediatric and adult devices is complex and multifactorial. This review aims to summarize the medical device landscape, describe barriers to pediatric device development, and provide an update on current strategies to help overcome these limitations. Medical devices are regulated by the Food and Drug Administration. They

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