U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 814Subpart 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.
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