Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 812 - Investigational Device Exemptions |
Subpart D - IRB Review and Approval |
§ 812.60 - IRB composition, duties, and functions. |
§ 812.62 - IRB approval. |
§ 812.64 - IRB's continuing review. |
§ 812.65 - [Reserved] |
§ 812.66 - Significant risk device determinations. |