SUBPART H—Humanitarian Use Devices (§814.100 to §814.126)
- 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.