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.


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