Title 21

PART 814 SUBPART H

Subpart H - Humanitarian Use Devices Source:61 FR 33244, June 26, 1996, unless otherwise noted.

• 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.

21:8.0.1.1.11.7.1.1	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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