Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical
trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can
maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also
help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of
pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical
device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to
provide reference in promoting China's data extrapolation.