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Research Letter
August 9, 2022

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

Author Affiliations
  • 1Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts
  • 2Computational Health Informatics Program, Boston Children’s Hospital, Boston, Massachusetts
  • 3Department of Surgery, Harvard Medical School, Boston, Massachusetts
  • 4Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
JAMA. 2022;328(6):580-582. doi:10.1001/jama.2022.10041

Most medical devices have not been designed or tested for pediatric indications and are instead repurposed for use in children from adult applications.1 Such off-label use of medical devices does not account for the unique anatomy and physiology of pediatric patients, and clinical evidence on the effectiveness and safety of such interventions is often lacking.2,3

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