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 · 2022 · 10 citations · 4 references

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Abstract

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.

References

4