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FDA-HUMANITARIAN DEV
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Complete Document History
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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Complete Current Edition:
2010 EDITION - Guidance for HDE Holders, Institutional Review Boards (IRBs) - July 8, 2010
Obsolete Revision Information:
2018 DRAFT - Draft Guidance for Industry and Food and Drug Administration Staff - June 13, 2018
2014 DRAFT - Draft Guidance for HDE Holders, Institutional Review Boards, - March 18, 2014
2001 EDITION - HUMANITARIAN DEVICE EXEMPTION - July 12, 2001