The FDA review process for cardiac medical devices in children: A review for the clinician

Pediatric medical devices play a vital role in the treatment of children with cardiovascular disease. Most cardiac medical devices used in children today are used off-label where the risk–benefit of devices has not been well characterized. Pediatric medical devices face a variety of challenges to FDA approval largely due to the small target population, heterogeneity of the patient population and ethical considerations around device testing in children. While relatively few cardiac devices have received FDA approval in children, the number of devices navigating the approval process successfully appears to be growing. Most pediatric device approvals are being granted through the humanitarian device exemption (HDE) pathway, which is designed for rare diseases and therefore suitable for devices intended to treat most forms of congenital heart disease. This review summarizes the FDA review process for pediatric cardiovascular medical devices as it continues to evolve in response to the unique challenges of evaluating device performance in children with cardiovascular disease.