Subpart H. 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.