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
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
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."
