US Food and Drug Administration approval of high-risk cardiovascular devices for use in children and adolescents, 1977-2021

Published in JAMA, 2022

Recommended citation: Susmitha Wunnava, Timothy A Miller, Claire Narang, Meena Nathan, and Florence T Bourgeois. 2022. US Food and Drug Administration approval of high-risk cardiovascular devices for use in children and adolescents, 1977-2021. In JAMA. https://jamanetwork.com/journals/jama/articlepdf/2795037/jama_wunnava_2022_ld_220043_1659634162.5982.pdf

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.