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Expert Review of Medical Devices Volume 6, 2009 - Issue 2
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Special Report

Device safety and effectiveness in the pediatric population: a US FDA perspective

Joy Samuels-Reid Division of Anesthesiology, General Hospital; and, Infection Control and Dental Devices; and, Center for Devices and Radiological Health, Office of Device Evaluation, FDA, 9200 Corporate Blvd. Rockville, MD 20857, USA. [email protected]
,
Judith U Cope Office of the Commissioner and Office of Pediatric Therapeutics, FDA, 5600 Fishers Lane, Rockville, MD 20857, USA. [email protected]
&
Audrey E Morrison Division of Postmarket Surveillance, Office of Surveillance and Biometrics,Center for Devices and Radiological Health, FDA, Rockville, MD 20857, USA. [email protected],gov
Pages 131-135 | Published online: 09 Jan 2014

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Read on this site (2)

Joy H. Samuels-Reid & Judith U. Cope. (2019) Medical devices and the pediatric population – a head-to-toe approach. Expert Review of Medical Devices 16:8, pages 647-652.
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Joy Samuels-Reid, Brenda Lawrence, Courtney Millin & Judith Cope. (2012) Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective. Expert Review of Medical Devices 9:3, pages 275-282.
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Articles from other publishers (4)

Giuseppina Spitaletta, Valentina Biagioli, Francesca Greco, Rachele Mascolo, Annachiara Liburdi, Giulia Manzi, Orsola Gawronski, Riccardo Ricci, Emanuela Tiozzo, Ercole Vellone, Teresa Grimaldi Capitello, Michele Salata, Massimiliano Raponi & Immacolata Dall’Oglio. (2023) Self-care in children and young people with complex chronic conditions: a qualitative study using Emotional Text Mining. Frontiers in Pediatrics 11.
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Samuel J. Lee, Lauren Cho, Eyal Klang, James Wall, Stefano Rensi & Benjamin S. Glicksberg. (2021) Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications. JAMA Network Open 4:6, pages e2112562.
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Priya Venkataraman-Rao & Joy H. Samuels-Reid. 2013. Pediatric Drug Development. Pediatric Drug Development 177 191 .
Cunlin Wang, Brock Hefflin, Judith U. Cope, Thomas P. Gross, Mary Beth Ritchie, Youlin Qi & Jianxiong Chu. (2010) Emergency Department Visits for Medical Device-Associated Adverse Events Among Children. Pediatrics 126:2, pages 247-259.
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