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Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration Staff

FDA-HUMANITARIAN DEV - 2018 DRAFT - DRAFT
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Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers


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Document Number

FDA-HUMANITARIAN DEV

Revision Level

2018 DRAFT

Status

Draft

Publication Date

June 13, 2018

Page Count

54 pages