Safe Medical Devices for Children

Questions? Call 800-624-6242

About | Ordering | New

LoginRegister

| Items in cart [0]

HARDBACK
price:$64.95
add to cart

Rights & Permissions

Free PDF Access

Free Resources

Related Titles

Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years
Other Related Titles

Safe Medical Devices for Children (2005)
Board on Health Sciences Policy (HSP)

Citation Manager

. "Appendix A Study Origins and Activities." Safe Medical Devices for Children. Washington, DC: The National Academies Press, 2005.

Please select a format:

Page
287


E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.

Safe Medical Devices for Children

Donya Hartley

Melisande Statz-Hill and Benjamin Hill

Penny Hill and Amanda Hill

Kim L. Katka

Karen Marston

Page
287

Front Matter (R1-R22)

Summary (1-16)

1 Introduction (17-45)

2 Medical Devices for Infants, Children, and Adolescents (46-72)

3 Regulatory Framework for Postmarket Surveillance of Medical Devices (73-111)

4 Identifying and Understanding Adverse Medical Device Events (112-182)

5 Monitoring of Postmarket Study Commitments Involving Medical Devices (183-198)

6 Adequacy of Pediatric Postmarket Surveillance Studies (199-228)

7 Children and Medical Device Safety: A Shared Responsibility (229-249)

References (250-278)

Appendix A Study Origins and Activities (279-287)

Appendix B Medical Devices for Pediatric Care (288-301)

Appendix C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context (302-326)

Appendix D Questions and Methods in Surveillance Programs (327-346)

Appendix E The Regulatory History of Cerebrospinal Fluid Shunts for Hydrocephalus (347-381)

Appendix F Cochlear Implants in Children A Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance (382-421)

Appendix G Glossary and Acronyms (422-432)

Appendix H Committee Biographical Statements (433-438)

Index (439-458)

Free PDF Access

Free Resources

Related Titles

Safe Medical Devices for Children (2005) Board on Health Sciences Policy (HSP)

Citation Manager

Safe Medical Devices for Children (2005)
Board on Health Sciences Policy (HSP)