Pathways to approval of pediatric cardiac devices in the United States: Challenges and solutions

Robert H. Beekman, Brian W. Duncan, Donald J. Hagler, Thomas K. Jones, John D. Kugler, John W. Moore, Kathy J. Jenkins

Research output: Contribution to journalReview article

13 Scopus citations

Abstract

Patients treated by pediatric interventional cardiologists and cardiac surgeons often have unmet medical device needs that pose a challenge to the current regulatory evaluation and approval process in the United States. In this report we review current US Food and Drug Administration regulatory processes, review some unique aspects of pediatric cardiology and cardiac surgery that pose challenges to these processes, and discuss possible alternate pathways to cardiac device evaluation and approval for children. Children deserve to benefit from new and refined cardiac devices and technology designed explicitly for their conditions.

Original languageEnglish (US)
Pages (from-to)e155-e162
JournalPediatrics
Volume124
Issue number1
DOIs
StatePublished - Jul 2009

Keywords

  • Cardiac devices
  • Device approval
  • Medical devices
  • Pediatric cardiology

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Fingerprint Dive into the research topics of 'Pathways to approval of pediatric cardiac devices in the United States: Challenges and solutions'. Together they form a unique fingerprint.

  • Cite this

    Beekman, R. H., Duncan, B. W., Hagler, D. J., Jones, T. K., Kugler, J. D., Moore, J. W., & Jenkins, K. J. (2009). Pathways to approval of pediatric cardiac devices in the United States: Challenges and solutions. Pediatrics, 124(1), e155-e162. https://doi.org/10.1542/peds.2008-3726