 |
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 H - Humanitarian Use Devices |
| § 814.100 - Purpose and scope. |
| § 814.102 - Designation of HUD status. |
| § 814.104 - Original applications. |
| § 814.106 - HDE amendments and resubmitted HDE's. |
| § 814.108 - Supplemental applications. |
| § 814.110 - New indications for use. |
| § 814.112 - Filing an HDE. |
| § 814.114 - Timeframes for reviewing an HDE. |
| § 814.116 - Procedures for review of an HDE. |
| § 814.118 - Denial of approval or withdrawal of approval of an HDE. |
| § 814.120 - Temporary suspension of approval of an HDE. |
| § 814.122 - Confidentiality of data and information. |
| § 814.124 - Institutional Review Board requirements. |
| § 814.126 - Postapproval requirements and reports. |