21 CFR Part 814 - 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.
Source:
61 FR 33244, June 26, 1996, unless otherwise noted.