What is a humanitarian use device?

A humanitarian use device is a device used in treating rare medical conditions.

What are some examples of humanitarian use devices?

The FDA has approved such humanitarian use devices as: a device to treat urinary tract obstruction in unborn babies; an electrical bladder stimulator for use in children; a pulmonary valve for children younger than four years of age; and a device for treating certain patients with hemophilia (a blood disorder).

Impact of the Food and Drug Administration Modernization Act of 1997

The Food and Drug Administration Modernization Act of 1997 contains a humanitarian use device exemption which permits the marketing of such a device without requiring proof of its effectiveness. Under the relaxed standard, the manufacturer is required to obtain pre-market approval by the FDA. However, the manufacturer is only required to show that the device does not have a significant risk of injury or illness and that its benefit outweighs any risk associated with its use.

Impact of the Safe Medical Devices Act of 1990

The FDA also issued a rule to implement the humanitarian use device provisions of the Safe Medical Devices Act of 1990. An applicant seeking pre-market approval must show that no similar device is available to treat the condition and that it would be impossible to bring the device to market without being classified as a humanitarian use device. A patient must be informed of any risks associated with the use of the device and must approve its use. An Institutional Review Board (IRB) has to conduct ongoing reviews of the device's use at least annually. As a general rule, only approved uses of the device are permitted. However, off-label use of the device (a use outside of the device's approved indications for use) is allowed in an emergency if the device could protect a patient or save the patient's life.

Copyright 2010 LexisNexis, a division of Reed Elsevier Inc.