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

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   2018 DRAFT - Draft Guidance for Industry and Food and Drug Administration Staff - June 13, 2018
   2014 DRAFT - Draft Guidance for HDE Holders, Institutional Review Boards, - March 18, 2014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