Subpart H—Humanitarian Use Devices

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 814
8. ›
9. Subpart H

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 814.100
  § 814.100 Purpose and scope.
• 814.102
  § 814.102 Designation of HUD status.
• 814.104
  § 814.104 Original applications.
• 814.106
  § 814.106 HDE amendments and resubmitted HDE's.
• 814.108
  § 814.108 Supplemental applications.
• 814.110
  § 814.110 New indications for use.
• 814.112
  § 814.112 Filing an HDE.
• 814.114
  § 814.114 Timeframes for reviewing an HDE.
• 814.116
  § 814.116 Procedures for review of an HDE.
• 814.118
  § 814.118 Denial of approval or withdrawal of approval of an HDE.
• 814.120
  § 814.120 Temporary suspension of approval of an HDE.
• 814.122
  § 814.122 Confidentiality of data and information.
• 814.124
  § 814.124 Institutional Review Board requirements.
• 814.126
  § 814.126 Postapproval requirements and reports.