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

@article{Beekman2009PathwaysTA,
  title={Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.},
  author={Robert H. Beekman and Brian W. Duncan and Donald J. Hagler and Thomas K. Jones and John Dale Kugler and John William Moore and Kathy J. Jenkins},
  journal={Pediatrics},
  year={2009},
  volume={124 1},
  pages={
          e155-62
        }
}
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… CONTINUE READING

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