Part 814 — Premarket Approval of Medical Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.
Sections
- § 814.1 Scope.
- § 814.2 Purpose.
- § 814.3 Definitions.
- § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
- § 814.15 Research conducted outside the United States.
- § 814.17 Service of orders.
- § 814.19 Product development protocol (PDP).
- § 814.20 Application.
- § 814.37 PMA amendments and resubmitted PMAs.
- § 814.39 PMA supplements.
- § 814.40 Time frames for reviewing a PMA.
- § 814.42 Filing a PMA.
- § 814.44 Procedures for review of a PMA.
- § 814.45 Denial of approval of a PMA.
- § 814.46 Withdrawal of approval of a PMA.
- § 814.47 Temporary suspension of approval of a PMA.
- § 814.80 General.
- § 814.82 Postapproval requirements.
- § 814.84 Reports.
- § 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.