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. However, the HDE must contain sufficient information for
FDA to determine that the probable benefit to health outweighs the risk of injury or illness,
taking into account the probable risks and benefits of currently available devices or alternative
forms of treatment. Section 520(m)(2)(C). An approved HDE authorizes marketing of an HUD.
Under the statute, once the HDE is approved, the HDE holder is responsible for ensuring that the
approved HUD is only administered at institutions that have an IRB constituted and acting
pursuant to 21 CFR 56, including conducting continuing review of the use of the HUD. In
addition, an HUD should be administered only if such use has been approved by the Institutional
Review Board (IRB) located at the facility, or by a similarly constituted IRB that has agreed to
oversee such use and to which the local IRB has deferred in a letter to the HDE holder. An
HDE holder may wish to ensure that this happens by not shipping the HUD to the facility until it
has received confirmation of IRB approval.
NOTE: HUDs should not be used until AFTER the HDE applicant obtains approval of the HDE
from FDA and the IRB approves its use. IRBs should ensure that HDE approval has been
granted before approving the device for use at their institution.
