US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021

Susmitha Wunnava,Timothy A Miller,Claire Narang,Meena Nathan,Florence T Bourgeois

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION（2022）

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摘要

This study uses data from US Food and Drug Administration (FDA) databases to quantify approval of high-risk cardiovascular devices for use in pediatric populations and assess the clinical evidence supporting the approvals.

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关键词

adolescents,us food,drug administration approval,children,high-risk

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