Safe medical devices for children / Committee on Postmarket Surveillance of Pediatric Medical Devices, Board on Health Sciences Policy ; Marilyn J. Field and Hugh Tilson, editors ; Institute of Medicine of the National Academies
Introduction -- Medical Devices for Infants, Children, and Adolescents -- Regulatory Framework for Postmarket Surveillance of Medical Devices -- Identifying and Understanding Adverse Medical Device Events -- Monitoring of Postmarket Study Commitments Involving Medical Devices -- Adequacy of Pediatric Postmarket Surveillance Studies -- Children and Medical Device Safety: A Shared Responsibility
Notes
"This study was supported by Contract No. 223-01-2460, Task Order No. 11 between the National Academy of Sciences and the U.S. Food and Drug Administration."
