• Front Matter R1-R20

• Summary 1-14

• 1 Introduction 15-28

• 2 Key Medical-Device Legislative and Regulatory Actions 29-40

• 3 Components of US Medical-Device Regulation 41-84

• 4 The 510(k) Clearance Process 85-122

• 5 Postmarketing Surveillance, Compliance, and Enforcement 123-148

• 6 External Factors That Affect the Medical-Device Regulatory System 149-188

• 7 Conclusions and Recommendations 189-206

• Appendix A: History of Medical-Device Legislation and Regulation in the United States 207-278

• Appendix B: Committee Biographies 279-286

• Index 287-298

" 3 Components of US Medical-Device Regulation ." Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years . Washington, DC: The National Academies Press, 2011 .

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