TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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.
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Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.
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