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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 - 2010 EDITION - CURRENT
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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

2010 EDITION

Status

Current

Publication Date

July 8, 2010

Page Count

30 pages