Part 814 — Premarket Approval of Medical Devices
Subpart A — General
Subpart B — Premarket Approval Application (PMA)
Subpart C — FDA Action on a PMA
Subpart E — Postapproval Requirements
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.