Title 21

PART 814

Part 814 - Premarket Approval Of Medical Devices

PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES 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.

21:8.0.1.1.11.1SUBPART A
Subpart A - General
21:8.0.1.1.11.1.1.1SECTION 814.1
   814.1 Scope.
21:8.0.1.1.11.1.1.2SECTION 814.2
   814.2 Purpose.
21:8.0.1.1.11.1.1.3SECTION 814.3
   814.3 Definitions.
21:8.0.1.1.11.1.1.4SECTION 814.9
   814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
21:8.0.1.1.11.1.1.5SECTION 814.15
   814.15 Research conducted outside the United States.
21:8.0.1.1.11.1.1.6SECTION 814.17
   814.17 Service of orders.
21:8.0.1.1.11.1.1.7SECTION 814.19
   814.19 Product development protocol (PDP).
21:8.0.1.1.11.2SUBPART B
Subpart B - Premarket Approval Application (PMA)
21:8.0.1.1.11.2.1.1SECTION 814.20
   814.20 Application.
21:8.0.1.1.11.2.1.2SECTION 814.37
   814.37 PMA amendments and resubmitted PMAs.
21:8.0.1.1.11.2.1.3SECTION 814.39
   814.39 PMA supplements.
21:8.0.1.1.11.3SUBPART C
Subpart C - FDA Action on a PMA
21:8.0.1.1.11.3.1.1SECTION 814.40
   814.40 Time frames for reviewing a PMA.
21:8.0.1.1.11.3.1.2SECTION 814.42
   814.42 Filing a PMA.
21:8.0.1.1.11.3.1.3SECTION 814.44
   814.44 Procedures for review of a PMA.
21:8.0.1.1.11.3.1.4SECTION 814.45
   814.45 Denial of approval of a PMA.
21:8.0.1.1.11.3.1.5SECTION 814.46
   814.46 Withdrawal of approval of a PMA.
21:8.0.1.1.11.3.1.6SECTION 814.47
   814.47 Temporary suspension of approval of a PMA.
21:8.0.1.1.11.4SUBPART D
Subpart D - Administrative Review [Reserved]
21:8.0.1.1.11.5SUBPART E
Subpart E - Postapproval Requirements
21:8.0.1.1.11.5.1.1SECTION 814.80
   814.80 General.
21:8.0.1.1.11.5.1.2SECTION 814.82
   814.82 Postapproval requirements.
21:8.0.1.1.11.5.1.3SECTION 814.84
   814.84 Reports.
21:8.0.1.1.11.6SUBPART F
Subparts F-G [Reserved]
21:8.0.1.1.11.7SUBPART H
Subpart H - Humanitarian Use Devices
21:8.0.1.1.11.7.1.1SECTION 814.100
   814.100 Purpose and scope.
21:8.0.1.1.11.7.1.2SECTION 814.102
   814.102 Designation of HUD status.
21:8.0.1.1.11.7.1.3SECTION 814.104
   814.104 Original applications.
21:8.0.1.1.11.7.1.4SECTION 814.106
   814.106 HDE amendments and resubmitted HDE's.
21:8.0.1.1.11.7.1.5SECTION 814.108
   814.108 Supplemental applications.
21:8.0.1.1.11.7.1.6SECTION 814.110
   814.110 New indications for use.
21:8.0.1.1.11.7.1.7SECTION 814.112
   814.112 Filing an HDE.
21:8.0.1.1.11.7.1.8SECTION 814.114
   814.114 Timeframes for reviewing an HDE.
21:8.0.1.1.11.7.1.9SECTION 814.116
   814.116 Procedures for review of an HDE.
21:8.0.1.1.11.7.1.10SECTION 814.118
   814.118 Denial of approval or withdrawal of approval of an HDE.
21:8.0.1.1.11.7.1.11SECTION 814.120
   814.120 Temporary suspension of approval of an HDE.
21:8.0.1.1.11.7.1.12SECTION 814.122
   814.122 Confidentiality of data and information.
21:8.0.1.1.11.7.1.13SECTION 814.124
   814.124 Institutional Review Board requirements.
21:8.0.1.1.11.7.1.14SECTION 814.126
   814.126 Postapproval requirements and reports.