Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

TEXT PDF814.1 Scope.
TEXT PDF814.2 Purpose.
TEXT PDF814.3 Definitions.
TEXT PDF814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
TEXT PDF814.15 Research conducted outside the United States.
TEXT PDF814.17 Service of orders.
TEXT PDF814.19 Product development protocol (PDP).
TEXT PDF814.20 Application.
TEXT PDF814.37 PMA amendments and resubmitted PMA's.
TEXT PDF814.39 PMA supplements.
TEXT PDF814.40 Time frames for reviewing a PMA.
TEXT PDF814.42 Filing a PMA.
TEXT PDF814.44 Procedures for review of a PMA.
TEXT PDF814.45 Denial of approval of a PMA.
TEXT PDF814.46 Withdrawal of approval of a PMA.
TEXT PDF814.47 Temporary suspension of approval of a PMA.
TEXT PDF814.80 General.
TEXT PDF814.82 Postapproval requirements.
TEXT PDF814.84 Reports.
TEXT PDF814.100 Purpose and scope.
TEXT PDF814.102 Designation of HUD status.
TEXT PDF814.104 Original applications.
TEXT PDF814.106 HDE amendments and resubmitted HDE's.
TEXT PDF814.108 Supplemental applications.
TEXT PDF814.110 New indications for use.
TEXT PDF814.112 Filing an HDE.
TEXT PDF814.114 Timeframes for reviewing an HDE.
TEXT PDF814.116 Procedures for review of an HDE.
TEXT PDF814.118 Denial of approval or withdrawal of approval of an HDE.
TEXT PDF814.120 Temporary suspension of approval of an HDE.
TEXT PDF814.122 Confidentiality of data and information.
TEXT PDF814.124 Institutional Review Board requirements.
TEXT PDF814.126 Postapproval requirements and reports.

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