FDA 21 CFR Part 814 Premarket Approval of Medical Devices

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Table of contents

Subpart A - General

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).

Subpart B - Premarket Approval Application (PMA)

814.20 Application.

814.37 PMA amendments and resubmitted PMAs.

814.39 PMA supplements.

Subpart C - FDA Action on a PMA

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.

Subpart D - Administrative Review [Reserved]

Subpart E - Postapproval Requirements

814.80 General.

814.82 Postapproval requirements.

814.84 Reports.

Subparts F-G [Reserved]

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.

FDA 21 CFR Part 814 Premarket Approval of Medical Devices: