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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

FDA-HUMANITARIAN DEV - 2014 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

2014 DRAFT

Status

Draft

Publication Date

March 18, 2014

Page Count

31 pages