Humanitarian Use Device

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 fewer than 4,000 individuals in the United States per year.

You can request a Humanitarian Device Exemption (HDE) from the FDA. It is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of sections 514 and 515 of the Food, Drug and Cosmetic Act.  

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Using HUDs in emergency use situations

If a physician in an emergency situation determines that IRB approval for the use of the HUD at the facility cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be used without prior IRB approval.

The physician must, within five (5) days after the emergency use of the device, provide written notification of the use to the IRB chairperson.

  • The written notification must include the identification of the patient involved, the date of the use and the reason for the use. 
  •     See section 520(m)(4) of the FD&C Act; 21 CFR 814.124.
Questions re HUD applications

Contact Lynn Jagodzinski

Phone: (716) 888-4843 orĀ

Additional references

You can learn more about HUDs at the FDA website.

How do we complete a HUD application?

In order to obtain HUD designation, you must provide documentation, with appended authoritative references, to demonstrate that the device meets the definition of 21 CFR 814.3(n). In addition to describing the disease or condition, you also must provide the proposed indications for use of the device and the reasons why such a device is needed for the patient population.

If the HUD application is designated, then you can submit the HDE marketing application to the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) for marketing review.

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

However, the application must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use. You must take into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, you must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that you could not otherwise bring the device to market.

How much time does it take to complete a HUD application?

Due to the amount and complexity of the data required for a HUD application, it can take several weeks to complete the submission. Therefore, we recommend you begin working on the submission as early as possible.

Information needed for the HUD application

To provide a more expeditious review of a HUD designation request, the FDA Office of Orphan Products Development (OOPD) suggests the following be provided as part of the request.

  1. Two copies of the request (the original and one additional copy).
  2. Cover letter with a statement that the applicant is requesting HUD designation for a rare disease or condition or a valid (medically plausible) subset of a disease or condition.
  3. Table of contents to include the following subsections:
    • Name and address of the applicant and contact person
    • Indication for use of the device
    • Description of the rare disease
    • Description of the device and the scientific rationale for its use as proposed
    • Population determination
    • Bibliography
    • Copies of all cited references
    • Appendices (if applicable)
  4. Pagination/Tabs corresponding to the Table of Contents. Please be sure that the following details are contained within each subsection:
    • Contact person: Include telephone and facsimile numbers and e-mail address
    • Description of disease: Include the current standard treatments
    • Description of device and its use: Include drawings/diagrams, etc. For the specific proposed indication and disease, explain the scientific rationale for the use of the device for the disease and why this device is needed, e.g., it can be used in place of more invasive procedures, etc.
  5. Population Estimate (based on the incidence of the condition in the United States):
    • If the device is proposed for an indication that represents a subset of a common disease, justify why that the subset is a medically plausible subset, e.g., the device cannot be used to treat/diagnose other subsets because...
    • If the device is for a diagnostic purpose, demonstrate that fewer than 4,000 patients per year would be subjected to diagnosis by the device in the United States.
    • Provide the authoritative references to demonstrate the number of patients that will use this device per year. The disease must be one that affects or is manifested in fewer than 4000 people in the U.S. per year.
    • Note: supporting population documentation may include peer-reviewed literature citations, textbooks, specialized medical society proceedings or governmental statistics publications (National Hospital Discharge Survey, National inpatient Profile, etc.).

When adequate studies or literature citations do not exist, OOPD will accept written statements from three independent experts in the field if they contain adequate justification for the population estimates.