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    Institutional Review Board (IRB) - Humanitarian Use Device Application Form

    Printer-friendly version: Humanitarian Use Device Application Form [MSWord 72KB]
    If you have problems using the Word document, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, 5th Floor, P-Campus,
    San Francisco, CA 94115

    For questions and help, please call:
    Leigh Pruneau, PhD, RN, CIP., Human Research Protection Program Administrator at (415) 600-3688.

    Please provide the following information for Humanitarian Use Device Application

    • Physician's name:
    • Sutter Affiliation:
    • Department.:
    • Mailing Address:
    • Phone Number:
    • Fax Number:
    • E-mail address:
    • If you wish to designate a contact other than the PI to receive correspondence regarding this IRB submission, please include their information: Name of Contact and E-mail address
    • IRB Protocol Title:
    • Device manufacturer information (Name, address, contact name, and telephone number)
    • Generic and trade name of the device:
    • FDA Humanitarian Device Exception number (HDE #):
    • Date of Humanitarian Use Device (HUD) designation:
    • Description of device:
    • Indications for use of the device:
    • Contraindications, warnings, precautions for the use of the device:
    • Alternative FDA-approved practices and procedures:
    • Please describe consent process and provide documentation: The investigator should address how, when and by whom consent will be obtained as part of the study. Will consent be given by designee?
    • Potential risks/discomforts to patients and methods of minimizing these risks:
    • Potential direct benefits to patients:
    • How many patients at CPMC will use device?
    • Affiliate site where research will be conducted:

    Physician's acknowledgement that the information provided above is complete and correct


    Provide Physician’s Signature/date

    Guidelines

    The information below provides a brief overview of the Humanitarian Device Exemption under Federal Regulations.

    1. What is a Humanitarian Device Exemption (HDE)? A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but exempt from the effectiveness requirements of a PMA. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD).
    2. What is a Humanitarian Use Device (HUD)? As defined in the Federal Food, Drug, and Cosmetic Act (the act), a HUD is a device that is “intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States.” In the final regulation, however, FDA added the qualifying phrase “per year” to the defining criteria.
    3. Who is responsible for ensuring that a HUD is not administered to or implanted in a patient prior to obtaining IRB approval at a health care facility? The healthcare provider is responsible for obtaining IRB approval before the HUD is administered to or implanted in a patient. The HDE holder is responsible for ensuring that the HUD is only used in facilities having an IRB constituted and acting in accordance with Part 56.
    4. Why does an IRB need to review and approve the use of the HUD at their institution? 21 CFR 814.124(a) require IRB review and approval before a HUD is used.
    5. What types of reviews are IRBs responsible for with respect to HUDs? IRBs are responsible for initial as well as continuing review of the HUD. For initial review of a HUD, IRBs are required to perform a full board review.
    6. Does an IRB have to review and approve each individual use of the humanitarian use device (HUD)?  No. The IRB does not need to review and approve individual uses of a HUD. As long as the use of the HUD is within the FDA approved indication, the IRB may approve use of the device however it sees fit. That is, the IRB may approve use of the HUD without any further restrictions, use of the device under a protocol, or use of the device on a case-by-case basis. In reviewing use of the HUD, IRBs should be cognizant that the use of the device should not exceed the scope of the FDA approved indication.
    7. Is informed consent required when treating/diagnosing a patient with a HUD? The Federal Food, Drug, and Cosmetic Act (the act) and the HDE regulation do not require informed consent because an HDE provides for marketing approval, and so use of the HUD does not constitute research or an investigation which would normally require informed consent. Although neither the act nor the regulation requires informed consent, there is nothing in the law or regulation that preempts a state or institution from requiring prospective informed consent. Most HDE holders, however, have developed patient labeling that incorporates information to assist a patient in making an informed decision about the use of the device. That is, the patient labeling contains a discussion of the potential risks and benefits of the device as well as any procedures associated with the use of the HUD. It also states that the device is a humanitarian use device for which effectiveness for the labeled indication has not been demonstrated.
    8. What if the HDE holder decides to collect safety and effectiveness data to support a PMA? Is an IDE needed? Is IRB approval and informed consent required? An HDE holder may collect safety and effectiveness data to support a PMA under the approved HDE (i.e., no IDE is needed). If the HUD is the subject of a clinical investigation, (one in which safety and effectiveness data is being collected to support a PMA), IRB approval and informed consent are required. (21 CFR Parts 56 and 50).