Version
1.1
Date Updated
Saturday, February 4, 2012
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 200
AAHRPP Elements: I.5.A.


DEFINITIONS


  1. HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit patients
    by treating or diagnosing a disease or condition that affects fewer than 4,000
    individuals in the United States per year.
  2. HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
    (FDA) approval of an HDE permits the marketing of an HUD, subject to restrictions
    on charges and use. Specifically, HUDs cannot be sold for profit, except in the
    limited circumstance when indicated for use in children, and can only be
    administered in facilities after IRB approval is obtained, except in certain
    emergencies. Approval of an HDE requires evidence of safety and probable benefit
    but does not require establishing effectiveness.