This study evaluates the quantity and supporting clinical evidence of high-risk cardiovascular devices approved by the FDA for pediatric use between 1977 and 2021.
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Pediatric device gaps signal need for targeted development; leaves open optimal evidence thresholds for FDA labeling.
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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Wunnava et al. (2022) studied this question.
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