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 814 - Premarket Approval of Medical Devices |
Subpart A - General |
§ 814.1 - Scope. |
§ 814.2 - Purpose. |
§ 814.3 - Definitions. |
§ 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file. |
§ 814.15 - Research conducted outside the United States. |
§ 814.17 - Service of orders. |
§ 814.19 - Product development protocol (PDP). |