REGULATIONS
Rulings
AD/CVD
Notices
HTSUS
U.S. Code
Regs
More
Ports
About
Updates
Apps
Larger font
Smaller font
SEARCH
Sort by Rank
Titles Ascending
Titles Descending
10 per page
25 Result/page
50 Result/page
Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 814
Subpart H - 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.
authority:
21 U.S.C. 351
,
352
,
353
,
360
,
360
c-360j,
360
bbb-8b,
371
,
372
,
373
,
374
,
375
,
379
,
379
e,
379
k-1,
381
source:
51 FR 26364, July 22, 1986, unless otherwise noted.
.list_box li,p,.cm-search-info,.cm-search-detail,.abt span,.expand-collapse_top
Get the CustomsMobile app!