Title 21

PART 814

Part 814 - Premarket Approval Of Medical Devices

PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES 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.

• 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.

21:8.0.1.1.11.1	SUBPART A	Subpart A - General
21:8.0.1.1.11.1.1.1	SECTION 814.1	814.1 Scope.
21:8.0.1.1.11.1.1.2	SECTION 814.2	814.2 Purpose.
21:8.0.1.1.11.1.1.3	SECTION 814.3	814.3 Definitions.
21:8.0.1.1.11.1.1.4	SECTION 814.9	814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
21:8.0.1.1.11.1.1.5	SECTION 814.15	814.15 Research conducted outside the United States.
21:8.0.1.1.11.1.1.6	SECTION 814.17	814.17 Service of orders.
21:8.0.1.1.11.1.1.7	SECTION 814.19	814.19 Product development protocol (PDP).
21:8.0.1.1.11.2	SUBPART B	Subpart B - Premarket Approval Application (PMA)
21:8.0.1.1.11.2.1.1	SECTION 814.20	814.20 Application.
21:8.0.1.1.11.2.1.2	SECTION 814.37	814.37 PMA amendments and resubmitted PMAs.
21:8.0.1.1.11.2.1.3	SECTION 814.39	814.39 PMA supplements.
21:8.0.1.1.11.3	SUBPART C	Subpart C - FDA Action on a PMA
21:8.0.1.1.11.3.1.1	SECTION 814.40	814.40 Time frames for reviewing a PMA.
21:8.0.1.1.11.3.1.2	SECTION 814.42	814.42 Filing a PMA.
21:8.0.1.1.11.3.1.3	SECTION 814.44	814.44 Procedures for review of a PMA.
21:8.0.1.1.11.3.1.4	SECTION 814.45	814.45 Denial of approval of a PMA.
21:8.0.1.1.11.3.1.5	SECTION 814.46	814.46 Withdrawal of approval of a PMA.
21:8.0.1.1.11.3.1.6	SECTION 814.47	814.47 Temporary suspension of approval of a PMA.
21:8.0.1.1.11.4	SUBPART D	Subpart D - Administrative Review [Reserved]
21:8.0.1.1.11.5	SUBPART E	Subpart E - Postapproval Requirements
21:8.0.1.1.11.5.1.1	SECTION 814.80	814.80 General.
21:8.0.1.1.11.5.1.2	SECTION 814.82	814.82 Postapproval requirements.
21:8.0.1.1.11.5.1.3	SECTION 814.84	814.84 Reports.
21:8.0.1.1.11.6	SUBPART F	Subparts F-G [Reserved]
21:8.0.1.1.11.7	SUBPART H	Subpart H - Humanitarian Use Devices
21:8.0.1.1.11.7.1.1	SECTION 814.100	814.100 Purpose and scope.
21:8.0.1.1.11.7.1.2	SECTION 814.102	814.102 Designation of HUD status.
21:8.0.1.1.11.7.1.3	SECTION 814.104	814.104 Original applications.
21:8.0.1.1.11.7.1.4	SECTION 814.106	814.106 HDE amendments and resubmitted HDE's.
21:8.0.1.1.11.7.1.5	SECTION 814.108	814.108 Supplemental applications.
21:8.0.1.1.11.7.1.6	SECTION 814.110	814.110 New indications for use.
21:8.0.1.1.11.7.1.7	SECTION 814.112	814.112 Filing an HDE.
21:8.0.1.1.11.7.1.8	SECTION 814.114	814.114 Timeframes for reviewing an HDE.
21:8.0.1.1.11.7.1.9	SECTION 814.116	814.116 Procedures for review of an HDE.
21:8.0.1.1.11.7.1.10	SECTION 814.118	814.118 Denial of approval or withdrawal of approval of an HDE.
21:8.0.1.1.11.7.1.11	SECTION 814.120	814.120 Temporary suspension of approval of an HDE.
21:8.0.1.1.11.7.1.12	SECTION 814.122	814.122 Confidentiality of data and information.
21:8.0.1.1.11.7.1.13	SECTION 814.124	814.124 Institutional Review Board requirements.
21:8.0.1.1.11.7.1.14	SECTION 814.126	814.126 Postapproval requirements and reports.

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