High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021-Reference-Cited by-同舟云学术

High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021

Published:2023-01-01 Issue:1 Volume:177 Page:98
ISSN:2168-6203
Container-title:JAMA Pediatrics
language:en
Short-container-title:JAMA Pediatr

Author:

Pathak Kavya¹,Narang Claire²,Hwang Thomas J.³,Espinoza Juan C.⁴,Bourgeois Florence T.²⁵

Affiliation:

1. Harvard Medical School, Boston, Massachusetts

2. Computational Health Informatics Program, Boston Children’s Hospital, Boston, Massachusetts

3. Division of Urological Surgery, Department of Surgery, Brigham and Women’s Hospital, Boston, Massachusetts

4. Department of Pediatrics, Children’s Hospital Los Angeles, Los Angeles, California

5. Department of Pediatrics, Harvard Medical School, Boston, Massachusetts

Abstract

This cohort study examines the characteristics of high-risk therapeutic devices approved by the US Food and Drug Administration for use in children and adolescents between 2016 and 2021.

Publisher

American Medical Association (AMA)

Subject

Pediatrics, Perinatology and Child Health

Link

https://jamanetwork.com/journals/jamapediatrics/articlepdf/2798259/jamapediatrics_pathak_2022_ld_220043_1672265240.86771.pdf

Reference6 articles.

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2. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.;Beekman;Pediatrics,2009

3. Pediatric medical device development and regulation: current state, barriers, and opportunities.;Espinoza;Pediatrics,2022

4. Hwang? TJ, Kesselheim? AS, Bourgeois? FT. Postmarketing trials and pediatric device approvals.? Pediatrics. 2014;133(5):e1197-e1202. doi:10.1542/peds.2013-3348

5. US Food and Drug Administration. Premarket Approval (PMA). Updated September 19, 2022. Accessed September 25, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm

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