Title 21, Part 814 — Premarket Approval of Medical Devices
33 sections
Section 814.1
Scope.
Section 814.2
Purpose.
Section 814.3
Definitions.
Section 814.9
Confidentiality of data and information in a premarket approval application (PMA) file.
Section 814.15
Research conducted outside the United States.
Section 814.17
Service of orders.
Section 814.19
Product development protocol (PDP).
Section 814.20
Application.
Section 814.37
PMA amendments and resubmitted PMAs.
Section 814.39
PMA supplements.
Section 814.40
Time frames for reviewing a PMA.
Section 814.42
Filing a PMA.
Section 814.44
Procedures for review of a PMA.
Section 814.45
Denial of approval of a PMA.
Section 814.46
Withdrawal of approval of a PMA.
Section 814.47
Temporary suspension of approval of a PMA.
Section 814.80
General.
Section 814.82
Postapproval requirements.
Section 814.84
Reports.
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.