What are the responsibilities of the IRBs regarding HDEs?

  •  11/4/2020 04:08 AM

Initial review: Initial IRB approval should be performed at a convened IRB meeting. The IRB does not need to review and approve individual uses of an HUD, but rather the IRB may approve use of the device as it sees fit.

What is a humanitarian device exemption (HDE) application?

  •  11/4/2020 04:00 AM

A Humanitarian Device Exemption (HDE) application is similar to a PMA, but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.