CHAPTER 1 1
Federal Regulation of Medical Devices
Clinical Trial De sign/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 G ood Laboratory Practices
10. 2 Clinical Trial Design
| 课件名称： | 麻省理工大学：Design of Medical Device |
| 课件分类： | 生物 |
| 课件类型： | 电子教案 |
| 文件大小： | 162.46KB |
| 下载次数： | 1 |
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- 1. 麻省理工大学：Design of Medical Device：chapter_1
- 2. 麻省理工大学：Design of Medical Device：chapter_10
- 3. 麻省理工大学：Design of Medical Device：chapter_11
- 4. 麻省理工大学：Design of Medical Device：chapter_2
- 5. 麻省理工大学：Design of Medical Device：chapter_3
- 6. 麻省理工大学：Design of Medical Device：chapter_4
- 7. 麻省理工大学：Design of Medical Device：chapter_5
- 8. 麻省理工大学：Design of Medical Device：chapter_6
- 9. 麻省理工大学：Design of Medical Device：chapter_7
- 10. 麻省理工大学：Design of Medical Device：chapter_8
- 11. 麻省理工大学：Design of Medical Device：chapter_9
