eCFR Reference Browser

§814.1 - Scope.

Title 21, Part 814

§814.100 - Purpose and scope.

Title 21, Part 814

§814.102 - Designation of HUD status.

Title 21, Part 814

§814.104 - Original applications.

Title 21, Part 814

§814.106 - HDE amendments and resubmitted HDE's.

Title 21, Part 814

§814.108 - Supplemental applications.

Title 21, Part 814

§814.110 - New indications for use.

Title 21, Part 814

§814.112 - Filing an HDE.

Title 21, Part 814

§814.114 - Timeframes for reviewing an HDE.

Title 21, Part 814

§814.116 - Procedures for review of an HDE.

Title 21, Part 814

§814.118 - Denial of approval or withdrawal of approval of an HDE.

Title 21, Part 814

§814.120 - Temporary suspension of approval of an HDE.

Title 21, Part 814

§814.122 - Confidentiality of data and information.

Title 21, Part 814

§814.124 - Institutional Review Board requirements.

Title 21, Part 814

§814.126 - Postapproval requirements and reports.

Title 21, Part 814

§814.15 - Research conducted outside the United States.

Title 21, Part 814

§814.17 - Service of orders.

Title 21, Part 814

§814.19 - Product development protocol (PDP).

Title 21, Part 814

§814.2 - Purpose.

Title 21, Part 814

§814.20 - Application.

Title 21, Part 814

§814.3 - Definitions.

Title 21, Part 814

§814.37 - PMA amendments and resubmitted PMAs.

Title 21, Part 814

§814.39 - PMA supplements.

Title 21, Part 814

§814.40 - Time frames for reviewing a PMA.

Title 21, Part 814

§814.42 - Filing a PMA.

Title 21, Part 814

§814.44 - Procedures for review of a PMA.

Title 21, Part 814

§814.45 - Denial of approval of a PMA.

Title 21, Part 814

§814.46 - Withdrawal of approval of a PMA.

Title 21, Part 814

§814.47 - Temporary suspension of approval of a PMA.

Title 21, Part 814

§814.80 - General.

Title 21, Part 814

§814.82 - Postapproval requirements.

Title 21, Part 814

§814.84 - Reports.

Title 21, Part 814

§814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

Title 21, Part 814

Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

Description

Official eCFR Link

§814.1 - Scope.

§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.

§814.15 - Research conducted outside the United States.

§814.17 - Service of orders.

§814.19 - Product development protocol (PDP).

§814.2 - Purpose.

§814.20 - Application.

§814.3 - Definitions.

§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.

§814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.