Current US FDA regulatory processes pose challenges for pediatric cardiac device approval, necessitating alternate pathways to ensure children benefit from appropriately designed technology.
This report highlights the challenges in the FDA regulatory process for pediatric cardiac devices and discusses potential alternate pathways to improve access to new technologies for children.
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.
Beekman et al. (Mon,) conducted a review in Pediatric cardiac device needs. Pediatric cardiac devices was evaluated. Current US FDA regulatory processes pose challenges for pediatric cardiac device approval, necessitating alternate pathways to ensure children benefit from appropriately designed technology.