Literature DB >> 35943478

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

Susmitha Wunnava1, Timothy A Miller2, Claire Narang2, Meena Nathan3, Florence T Bourgeois4.   

Abstract

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Mesh：

Year:  2022        PMID： 35943478      PMCID： PMC9364120          DOI： 10.1001/jama.2022.10041

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   157.335


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  5 in total

1.  Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.

Authors:  Robert H Beekman; Brian W Duncan; Donald J Hagler; Thomas K Jones; John D Kugler; John W Moore; Kathy J Jenkins
Journal:  Pediatrics       Date:  2009-07       Impact factor: 7.124

2.  Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices.

Authors:  Jamie S Sutherell; Russel Hirsch; Robert H Beekman
Journal:  Congenit Heart Dis       Date:  2010 Jan-Feb       Impact factor: 2.007

3.  FDA's pediatric device consortia: national program fosters pediatric medical device development.

Authors:  Linda C Ulrich; Francesca D Joseph; Debra Y Lewis; Robert L Koenig
Journal:  Pediatrics       Date:  2013-04-08       Impact factor: 7.124

4.  The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation.

Authors:  S H Rahimtoola; G A Rahmoeller
Journal:  Circulation       Date:  1980-11       Impact factor: 29.690

5.  Off-Label Use of Medical Devices in Children.

Authors: 
Journal:  Pediatrics       Date:  2017-01       Impact factor: 7.124
  5 in total

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