We hope that this report will put a face on the children who benefit every day from medical devices, lend a voice to some of the challenges they face in realizing the benefits of the devices, and give heart to those who want to make things even better. In spirit, our report is for these children and their families. As written, this report responds to a request from Congress to investigate the questions described in the Summary and Chapter 1, and we have aimed much of our analysis and recommendations at legislative and administrative policymakers and those who advise them. At the same time, we have also tried.