• Front Matter R1-R14

• 1 Introduction 1-4

• 2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices 5-22

• 3 Non–Food and Drug Administration Sources of Adverse Event Data 23-38

• 4 Postmarket Surveillance of Medical Devices: Panel Discussion 39-46

• 5 Other Select Topics 47-60

• Appendix A: Workshop Agenda 61-64

• Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers 65-72

• Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data 73-96

• Appendix D: Trustworthy Medical Device Software 97-118

" Front Matter ." Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report . Washington, DC: The National Academies Press, 2011 .

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