These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.
    Author: Beekman RH, Duncan BW, Hagler DJ, Jones TK, Kugler JD, Moore JW, Jenkins KJ, Workgroup on Pediatric Cardiac Devices, Section on Cardiology and Cardiac Surgery, American Academy of Pediatrics.
    Journal: Pediatrics; 2009 Jul; 124(1):e155-62. PubMed ID: 19564262.
    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.
    [Abstract] [Full Text] [Related] [New Search]