Population
Children requiring mechanical circulatory support
Design
Review
Key result
A 2006 FDA workshop highlighted that early interactions with regulators and careful planning are critical to address the challenges of developing pediatric mechanical circulatory support devices.
Authors
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Early FDA interactions may aid pediatric MCS device development; leaves open optimal strategies amid evolving regulations.
Developing pediatric mechanical circulatory support devices requires early FDA collaboration to navigate unique epidemiologic, logistic, and financial regulatory challenges.
Almond et al. (2007) conducted a review in Pediatric mechanical circulatory support. Pediatric mechanical circulatory support devices was evaluated. A 2006 FDA workshop highlighted that early interactions with regulators and careful planning are critical to address the challenges of developing pediatric mechanical circulatory support devices.