Use of computer and in vitro modeling techniques during the development of pediatric circulatory support devices: National heart, lung, and blood institute pediatric assist device contractor's meeting: Pediatric modeling techniques working group

Pediatric mechanical circulatory devices are currently being developed by several programs. Along with the engineering and testing challenges to be considered is the regulatory process which will be used to review applications to the Food and Drug Administration (FDA) to initiate clinical trials with these devices. This paper considers the appropriate use of computer and in vitro modeling data as a part of an FDA Investigational Device Exemption submission for a pediatric circulatory support device. Initially, the types and value of modeling techniques that may be used are discussed. How the unique physiology, flow requirements, and anatomy of pediatric patients may affect modeling efforts is then reviewed. Modeling assumptions, justification, and validation are key aspects of modeling data to be submitted as a part of an FDA submission. Finally, key recommendations are made for the appropriate use of modeling data for an FDA clinical trial submission.