Relationship between an FDA HDE - Join LeeTraux-Bellows in this 60 minutes power packed conference, What is the relationship between an FDA HDE (Humanitarian Device Exemption) @ HUD (Humanitarian Use Device) – or are they same?

1. What Is the Relationship between an FDA HDE (Humanitarian Device
Exemption) & HUD (Humanitarian Use Device) - or are they the same?
Product Format: Audio Conference
Presenter(s): Lee Truax Bellows
Even though Humanitarian Device Exemption (HDEs) and Humanitarian Use Device approvals (HUDs)
have been around for many years, most researchers and professionals have little or no knowledge of
differences between these two terms and also lack an understanding on how they are operationalized in
a real world setting.
Join LeeTraux-Bellows in this 60 minutes power packed conference, ‘What is the relationship between
an FDA HDE (Humanitarian Device Exemption) @ HUD (Humanitarian Use Device) – or are they same?’
due on Wed, May 14, 2014, to:
 Define an HDE and an HUD.
 Describe the basic process for obtaining HDE designation and HUD approval.
 Describe Sponsor responsibilities under an HUD approval.
 Describe IRB responsibilities under an HUD approval.
 Describe Clinical Investigator responsibilities under an HUD approval.
For more information, visit http://www.audioeducator.com/pharma-biotech/humanitarian-device-
exemption-05-14-14.html
Special Offer: Use code SAVE10 to get 10% discount.
Can’t attend? Request a replay of the audio session or DVD recording