Stanford IRB • SCRO • APLAC
IRB • SCRO Institutional Review Board IRB • SCRO • APLAC
IRB • SCRO • APLAC

Humanitarian Use Device (HUD) Program

The Humanitarian Device Exemption (HDE) Program allows for a regulatory pathway to use products intended to treat diseases or conditions that affect small (rare) populations. The use of a HUD is regulated by the FDA under 21 CFR 814. See additional FDA Guidance on the HDE Program. An HUD is a device intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.

This webpage includes information on the following:

Applying for a Humanitarian Device Exemption (HDE)

To obtain approval of an HUD for clinical use, the sponsor will submit an HDE application to the FDA. The HDE application must include sufficient information for the FDA to determine the following:

  1. The device is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States on an annual basis;
  2. The device will not expose patients to an unreasonable or significant risk of illness or injury;
  3. The probable benefit to health from use of the device outweighs the risk of injury or illness from its use while taking into account the probable risks and benefits of currently available devices or alternative forms of treatment; and
  4. The device would not be available to a person with the disease or condition in question without the HDE, and no comparable device, other than another device approved under an HDE or Investigation Device Exemption (IDE), is available to treat or diagnose such disease or condition.

The HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.

Criteria for HUD Use

The use of an HUD requires prospective IRB review and approval (except Emergency Use). For use of an HUD for either non-research or research purposes, an IRB application must be submitted via eProtocol for review by the convened IRB.

Non-research (Clinical) use:

  • The HUD may be used for its FDA approved indication only after IRB approval has been obtained. An HUD application should be submitted to the IRB for non-research use of an HUD.
  • The IRB may require patients receive a written document prior to use of the HUD, this document should include much of the information found in the HDE patient labeling. This document can be patient information packet or IRB approved consent form. See the section on Information to Patients in the FDA’s HDE Program Guidance for information that should be included in the consent form/patient information packet.
  • HUD use is subject to continuing review and approval by the IRB.
  • All adverse events, whether expected or not, must be reported and evaluated in accordance with Medical Device Report (MDR) requirements under 21 CFR 803. When available, the holder of the HDE must provide the MDR to the IRB.
  • MDRs must be submitted to the FDA and to the IRB promptly in accordance with 21 CFR 803.30 when:
    • The HUD may have caused or contributed to death or serious injury; or
    • The HUD has malfunctioned and likely cause or contribute to death or serious injury in the future if the malfunction recurs. 
Serious Injury

An injury or illness that

  • Is life threatening;
  • Results in permanent impairment of a body function or permanent damage to a body structure; or
  • Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
  • To use an HUD in clinical care for a new indication (e.g.; for a different disease or condition than its FDA approved indication), the IRB application should indicate this and should include the rationale.
  • To seek an HUD designation for a new indication, a new HDE must be submitted to the FDA; see 21 CFR 814.110.
  • Modifications to the HDE may require FDA review of 30 or 75 days. See FDA Guidance.

Research (Clinical Investigation) use:

Studying the safety and effectiveness of an HUD would be considered a research use of the device. For research under an HDE, the scope of the IRB approval is to confirm the planned use is consistent with the FDA-approved indication for the HDE. Data may be collected in a clinical investigation for the HDE approved indication(s) without an IDE.

Researchers who want to determine the safety or effectiveness of the HUD for a different indication than the HDE-approved indication(s), must submit an IDE application to FDA if the device is a significant risk device. The investigational use of an HUD under these circumstances is a clinical investigation and must be conducted in accordance with 21 CFR Parts 812, 50, 54, and 56. A Regular application should be submitted to the IRB for for a clinical investigation of an HUD.

If the HUD is being investigated in a clinical study under an IDE, adverse events that occur during the study should be reported in accordance with 21 CFR 812.150(a)(1) and 21 CFR 812.150(b)(1).

Resources

Page updated June, 2026