FrontMatter -- Preface -- Acknowledgments -- Reviewers -- Contents -- Boxes, Figures, and Tables -- Summary -- 1 Introduction -- 2 Medical Devices for Infants, Children, and Adolescents -- 3 Regulatory Framework for Postmarket Surveillance of Medical Devices -- 4 Identifying and Understanding Adverse Medical Device Events -- 5 Monitoring of Postmarket Study Commitments Involving Medical Devices -- 6 Adequacy of Pediatric Postmarket Surveillance Studies -- 7 Children and Medical Device Safety: A Shared Responsibility -- References -- Appendixes -- A Study Origins and Activities -- B Medical Devices for Pediatric Care -- C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context -- D Questions and Methods in Surveillance Programs -- E The Regulatory History of Cerebrospinal Fluid Shunts for Hydrocephalus -- F Cochlear Implants in Children: A Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance -- G Glossary -- H Committee Biographical Statements -- Index.