Biomedical Research

Humanitarian Use Device (HUD)

A Humanitarian Use Device (HUD) is defined as 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 (Orphan Diseases). An HUD is marketed under an HDE and is exempt from the requirement of establishing a reasonable assurance of effectiveness. Although the use of a HUD within its approved labeling does not constitute research, the FDA requires IRB approval be obtained before a HUD can be used in a facility.

Request Approval for Clinical Use of a Humanitarian Use Device (HUD)


Clinical Use refers to use of the HUD in accordance with its label, for treatment or diagnosis as part of clinical care (not for research purposes).


IRB Submission Requirements


The following documents should be submitted via an initial submission in HSERA when requesting to treat a patient with an HUD:

  • HUD Protocol Summary
  • Humanitarian Use Device Consent Form or the patient information brochure prepared by the manufacturer
  • The HUD manufacturer’s product labeling, clinical brochure, and/or other pertinent manufacturer informational materials
  • The FDA HDE approval letter
  • Cover letter with additional information that may help in the review
  • Document list identifying each attachment (name, version, date)

Training Requirements


Training must be fulfilled by CITI curriculum.

  • Physicians may take the full CITI Human Subjects Protections course if they are otherwise engaged in human subjects’ research.
  • Alternatively, physicians may take the standalone Humanitarian Use Devices (HUDs) module if they are NOT otherwise engaged in human subjects’ research. Within the CITI
  • Course Enrollment Questions, check the box next to Humanitarian Use Devices (HUDs).

The physician using the HUD has certain responsibilities, as outlined in the FDA regulations.

  • Obtain IRB approval and institutional clearances prior to first use of the HUD and maintain IRB approval (continuing review) as long as the HUD continues to be used in the institution.
  • Ensure that patients receive the labeling information prepared by the HDE holder or an informed consent form approved by the IRB.
  • Ensure that the device is used only by designated individuals in designated facilities approved for HUD use (i.e., individuals and facilities listed in the IRB approved protocol for HUD use).
  • Ensure that the HUD is used within the scope of its labeling, OR submit to the IRB if the proposed use is not within the scope of the approved labeling.
  • Report to the HDE holder/FDA and to the IRB any new risk information. In essence, report whenever a HUD may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur (21 CFR 814.126(a)).
  • Report any patient complaints to the IRB.

Single Patient Emergency or Compassionate Use of an HUD


A HUD may be used in the context of emergency or compassionate treatment of a single patient. Click below for more information and the submission requirements for these situations.

If a physician in an emergency situation determines that IRB / FDA approval for the use of an HUD cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be used within the scope of its labeling or off-label without prior IRB approval. Emergency use situations are those in which:

  • The patient has a life-threatening condition that needs immediate treatment;
  • No generally acceptable alternative treatment for the condition exists that provides an equal or greater likelihood of saving the subject’s life; AND
  • Because of the immediate need to use the device, there is insufficient time to contact the FDA or the IRB.
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If a physician in a non-emergent situation determines that there is no generally acceptable alternative treatment or device for the patient’s condition, the HUD may be used off-label in a compassionate use situation. However, IRB review is required prior to use.

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Request Approval for Investigational Use of a Humanitarian Use Device (HUD)

Investigational use refers to research/clinical investigation involving a HUD, off label or in accordance with its label.

Investigational use of a HUD in accordance with its label

If the investigational use is in accordance with the approved HDE label to collect safety and effectiveness data, please follow submission requirements linked below.

Investigational use of a HUD off-label

If the investigational use is NOT in accordance with the approved HDE label, please follow submission requirements linked below. A research informed consent form and a standalone protocol will be required. Depending on the proposed use, the use may require submission of an IDE application to the FDA, or be conducted under abbreviated requirements for NSR devices.

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