21 CFR Subpart H
Humanitarian Use Devices
June 25, 2020
§
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
§
814.100
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
§
814.122
Confidentiality of data and information
§
814.124
Institutional Review Board requirements
§
814.126
Postapproval requirements and reports
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