Humanitarian Use Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Premarket Approval of Medical Devices
  7. Humanitarian Use Devices

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Section
814.100

Purpose and scope.

Section
814.102

Designation of HUD status.

Section
814.104

Original applications.

Section
814.106

HDE amendments and resubmitted HDE's.

Section
814.108

Supplemental applications.

Section
814.110

New indications for use.

Section
814.112

Filing an HDE.

Section
814.114

Timeframes for reviewing an HDE.

Section
814.116

Procedures for review of an HDE.

Section
814.118

Denial of approval or withdrawal of approval of an HDE.

Section
814.120

Temporary suspension of approval of an HDE.

Section
814.122

Confidentiality of data and information.

Section
814.124

Institutional Review Board requirements.

Section
814.126

Postapproval requirements and reports.