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

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

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


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.

[PubMed - indexed for MEDLINE]
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