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Part 814
FEDERAL · 21 CFR
Part 814 — Premarket Approval of Medical Devices
33 sections · Title 21: Food and Drugs
§ 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.