Humanitarian Use Devices (HUDs)

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients with diseases or conditions that affect fewer than 8,000 people per year in the United States.

• HUD designation is granted by the FDA Office of Orphan Products Development
• HUDs are used to treat or diagnose rare conditions

Using a HUD for its approved purpose is generally considered clinical care, not research—unless you are collecting safety or effectiveness data.

A Humanitarian Device Exemption (HDE) is the FDA approval pathway that allows these devices to be marketed.

Unlike standard devices, HUDs approved under an HDE do not need to meet the same level of evidence for effectiveness. Instead, the FDA determines that:

• The device does not pose unreasonable risk
• The probable benefit outweighs the risk
• No comparable device is available
• The condition affects a small population

Before a HUD can be used at NIH:

• The NIH IRB must approve its use at the facility (e.g., Clinical Center)
• The initial review must occur at a convened IRB meeting

Once approved:

• The device can be used for its approved indication
• It may also be used off-label as part of clinical care

The IRB does not need to review each individual use once the HUD is approved for clinical use at the facility.

For clinical use of a HUD, patients must receive a patient information sheet.

This document must:

• Clearly state that the device’s effectiveness has not been proven
• Explain that the device is an FDA-approved HUD
• Describe its intended use

If the HUD is being used only for clinical care, the information sheet should not describe the use as research.

To obtain IRB approval for clinical use of a HUD, submit:

• FDA HDE approval documentation
• Device labeling
• Patient information materials
• A brief protocol describing:
  • The device
  • How it will be used
  • Target patient population
  • Screening and treatment plan
  • Reporting requirements

Use of a HUD becomes research (a clinical investigation) if you collect data on safety or effectiveness.

If used within the approved indication:

• You may collect data without an Investigational Device Exemption (IDE)
• The IRB does not need to make a significant risk (SR/NSR) determination

If used outside the approved indication:

• The study must follow FDA investigational device requirements
• IRB review and informed consent are required
• The IRB must determine whether the study is:
  • Significant Risk (SR) → requires FDA IDE approval
  • Non-Significant Risk (NSR)

If using a HUD in research:

• Report events to the sponsor as required
• Report Unanticipated Adverse Device Effects (UADEs) to the sponsor within 10 working days
• Report unanticipated problems to the IRB within 7 calendar days

A UADE includes any serious, unexpected problem related to the device that affects participant safety.

A HUD may be used without prior IRB approval in an emergency if:

• The patient has a serious or life-threatening condition
• There is not enough time to obtain IRB approval

In this situation:

• The device may be used based on physician certification
• The IRB Chair must be notified in writing within 5 days
• The report must include:
  • Patient identifier
  • Date of use
  • Reason for use

• Submit the protocol for continuing review, if applicable
• Follow FDA post-approval reporting requirements
• Follow FDA device reporting requirements
• Follow IRB reporting requirements

HUDs can be used for clinical care with IRB approval, but the use becomes research if you collect safety or effectiveness data. Investigators are responsible for understanding when additional regulatory requirements apply and ensuring appropriate IRB review.