Organization Policy on Humanitarian Use Devices (Policy No. FDA 814.1)
May 2005

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 fewer than 4,000 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'' (defined under (21 CFR 860.(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 review before a HUD may be used, either under a protocol or on a case-by-case basis.

It is the opinion of counsel for JHHS and JHU that consent must be obtained from patients who are to receive a HUD at Johns Hopkins, except for certain limited emergency use. A special HUD consent form template has been provided and is available on the JHM IRB website. The JHM IRB must approve each consent form.  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.

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 administered without prior approval by the JHM IRB, or concurrence of the IRB Chair and notify the IRB of such use. 

The JHM IRB will review the notification to assure that the emergency use of the HUD met with FDA regulations.  The physician will be notified of the outcome of this review.