science

Humanitarian Use Devices

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255).  A Humanitarian Device Exemption (HDE) is a marketing application for an HUD. An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions. “Use” of a HUD that has an approved HDE, requires IRB approval before use in a facility, with the exception of emergency use (see 21 CFR 814.124). The HDE holder is responsible for maintaining records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with reviewing IRBs, and any other information requested by the reviewing IRB or FDA (21 CFR 814.126(b)(2))

HUDs are subject to IRB oversight per FDA regulations. Initial review of an HUD must be performed at an IRB's convened meeting (21 CFR 56.108). The IRB may give blanket approval for the use of a particular HDE device at an institution, or it may give approval on a case-by-case basis.

How to Submit your HUD/HDE to the IRB:

Please note, if your HUD is needed for emergency use purposes, please refer to the Emergency and Compassionate Use page and submit this HUD as an emergency use. And if you plan to conduct research with this HUD, please refer to the Expedited & Full Committee Review page and submit this HUD as a new research study. Otherwise, you may follow the instructions below:

  1. Submit through eIRB as a new study.
  2. Upload the Humanitarian Use Device Protocol Form in the “Attach the Protocol” section of your eIRB submission.  If the device manufacturer has provided you a separate protocol for your HUD, please upload that as well.
  3. Complete the HRP-595 - TEMPLATE CONSENT DOCUMENT - Humanitarian Use Device as the informed consent form (ICF) for your HUD.
  4. Upload the following in the Devices page of the eIRB submission:
    1. A copy of the HDE approval order*;
    2. The product labeling*;
    3. The patient information packet/patient brochure that may accompany the HUD*;

*Note: A list of approved HDE applications may be found at https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions. The approval order, labeling, and patient information may be found by selecting the submission number of the appropriate HDE application.

FDA Resources