Literature DB >> 20559980

Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions.

Francesca Dolcimascolo1.   

Abstract

The advancement of pediatric medical devices is an important challenge currently facing the Food and Drug Administration and the medical community. In this manuscript, the challenges are described and possible solutions presented.

Mesh：

Year:  2009        PMID： 20559980     DOI： 10.1007/s12265-009-9100-2

Source DB:  PubMed          Journal:  J Cardiovasc Transl Res        ISSN： 1937-5387            Impact factor:   4.132


  3 in total

1.  The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician.

Authors:  Christopher S Almond
Journal:  Prog Pediatr Cardiol       Date:  2012-03-27

2.  Pediatric medical device development by surgeons via capstone engineering design programs.

Authors:  Bryan S Sack; Rodolfo A Elizondo; Gene O Huang; Nicolette Janzen; Jimmy Espinoza; Magdalena Sanz-Cortes; Jennifer E Dietrich; Julie Hakim; Eric S Richardson; Maria Oden; John Hanks; Balakrishna Haridas; James F Hury; Chester J Koh
Journal:  J Pediatr Surg       Date:  2017-02-06       Impact factor: 2.545

3.  Postmarketing trials and pediatric device approvals.

Authors:  Thomas J Hwang; Aaron S Kesselheim; Florence T Bourgeois
Journal:  Pediatrics       Date:  2014-04-14       Impact factor: 7.124
  3 in total

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