FDA working to ensure the safety of medical devices used in the pediatric population

Marilyn Neder Flack; Thomas P Gross; Joy Samuels Reid; Thalia T Mills; Jacqueline Francis

doi:10.1016/j.pcl.2012.08.003

FDA working to ensure the safety of medical devices used in the pediatric population

Pediatr Clin North Am. 2012 Dec;59(6):1355-66. doi: 10.1016/j.pcl.2012.08.003. Epub 2012 Oct 13.

Authors

Marilyn Neder Flack¹, Thomas P Gross, Joy Samuels Reid, Thalia T Mills, Jacqueline Francis

Affiliation

¹ Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD 20993, USA. Marilyn.flack@fda.hhs.gov

PMID: 23116531
DOI: 10.1016/j.pcl.2012.08.003

Abstract

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA.

Published by Elsevier Inc.

MeSH terms

Child
Equipment Safety*
Humans
Patient Safety*
Pediatrics
Product Surveillance, Postmarketing*
United States
United States Food and Drug Administration