CHAPTER 11 Federal regulation of Medical Devices Clinical trial Design/Outcome Studies: 10.1 Federal Regulation of Medical Devices 10.1. 1 The Law(including amendments) 10.1.2 Organization of FDA 10.1.3 Classification of Devices 10.1.4 Process of Assessment 10. 1.4.1 510(k)Substantial equivale 10. 1.4.2 Premarket Approval 10.1.5 Clinical Trials(Investigational Device Exemption) 10.1.6 Labeling 10. 1.7 Tripartite Biocompatibility guidanc L 8 Standard 10. 1.9 Good Manufacturing Procedure 10.1.10 Good Laboratory Practices 10.2 Clinical Trial Design
CHAPTER 11 Federal Regulation of Medical Devices Clinical Trial Design/Outcome Studies; 10.1 Federal Regulation of Medical Devices 10.1.1 The Law (including amendments) 10.1.2 Organization of FDA 10.1.3 Classification of Devices 10.1.4 Process of Assessment 10.1.4.1 510(k) Substantial Equivalence 10.1.4.2 Premarket Approval 10.1.5 Clinical Trials (Investigational Device Exemption) 10.1.6 Labeling 10.1.7 Tripartite Biocompatibility Guidance 10.1.8 Standards 10.1.9 Good Manufacturing Procedures 10.1.10 Good Laboratory Practices 10.2 Clinical Trial Design