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

doi:10.1001/jama.2022.10041

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

JAMA. 2022 Aug 9;328(6):580-582. doi: 10.1001/jama.2022.10041.

Authors

Susmitha Wunnava¹, Timothy A Miller², Claire Narang², Meena Nathan³, Florence T Bourgeois⁴

Affiliations

¹ Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts.
² Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts.
³ Department of Surgery, Harvard Medical School, Boston, Massachusetts.
⁴ Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.

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.

MeSH terms

Adolescent
Cardiovascular System*
Child
Device Approval* / legislation & jurisprudence
Equipment Safety
Humans
Risk
United States
United States Food and Drug Administration* / legislation & jurisprudence