Federal (United States) · Regulations
Subpart H — Humanitarian Use Devices
14 sections
14 sections
- 21 C.F.R. § 814.100Purpose and scope.
- 21 C.F.R. § 814.102Designation of HUD status.
- 21 C.F.R. § 814.104Original applications.
- 21 C.F.R. § 814.106HDE amendments and resubmitted HDE's.
- 21 C.F.R. § 814.108Supplemental applications.
- 21 C.F.R. § 814.110New indications for use.
- 21 C.F.R. § 814.112Filing an HDE.
- 21 C.F.R. § 814.114Timeframes for reviewing an HDE.
- 21 C.F.R. § 814.116Procedures for review of an HDE.
- 21 C.F.R. § 814.118Denial of approval or withdrawal of approval of an HDE.
- 21 C.F.R. § 814.120Temporary suspension of approval of an HDE.
- 21 C.F.R. § 814.122Confidentiality of data and information.
- 21 C.F.R. § 814.124Institutional Review Board requirements.
- 21 C.F.R. § 814.126Postapproval requirements and reports.