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FDA 814.1 Organization Policy on Humanitarian Use Devices

September 2020

The Organization allows use of Humanitarian Use Devices (HUD) at JHM. It is recognized that a HUD is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the United States per year. A HUD is approved for marketing through an HDE application. An HDE application is a Pre-Marketing Approval application that is not required to contain clinical data demonstrating "effectiveness'' (as defined under (21 CFR 860.7 (e)(1).) The FDA may grant HUD designation to a device which meets the criteria in 21 CFR 814.102, and marketing approval for an HUD device through a Humanitarian Device Exemption (HDE). Only HUDs with approved HDEs may be used at JHM. An investigator must apply for and receive JHM IRB approval before a HUD may be used, either under a protocol or on a case-by-case basis.

FDA regulations do not require use of an IRB-approved consent form for use of a HUD when the HUD is used according to the marketed HDE indications. The JHM IRBs may issue an Information Sheet to be presented to patients when JHM IRB approval is granted. If an emergency situation exists such that it would not be possible to obtain informed consent prior to the use of the HUD, the physician shall provide the patient with written information about the device following the use or procedure and notify the IRB of such use.

Off-Label Use of a HUD with JHM IRB Approval

The JHM IRB may approve off-label treatment use of the HUD. In such cases, the requesting physician must use the template consent form linked here: Humanitarian Use Device (HUD) Consent/Authorization Template but off-label use requires that a HUD research consent form must be used.

Continuing Reviews of HUD Approvals by the IRB

FDA guidance permits IRBs to conduct continuing review of HUD applications under an expedited procedure. If the JHM IRBs choose to allow expedited continuing reviews of HUDs used according to their approved indications, the expedited reviewer should consider the risk and benefit information available and any accompanying Medical Device Reporting (MDR) reports. In cases in which the JHM IRB’s approval for use of the HUD is for off-label indications, continuing review will be conducted in convened session.

Emergency Use of a HUD without time for JHM IRB Approval

In an emergency situation, if a physician determines that either JHM IRB approval, or concurrence from an IRB Chair, cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be used in treatment without prior approval by the JHM IRB, or concurrence of the IRB Chair. In such cases, the physician must notify the IRB by submitting an eIRB application within 5 days of the use. In this application the physician must describe the condition of the patient involved, the date on which the use of the HUD occurred, and the reason for the use.

(For additional reference, see FDA Guidance on Humanitarian Device Exemption (HDE) Program:

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