Institutional Review Board



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 not more than 8,000 individuals in the United States per year.  FDA regulations (21 CFR 814.124) provide for the submission of a Humanitarian Device Exemption (HDE) in which the manufacturer is not required to provide the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose prior to marketing. This regulation was developed to provide an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

When the manufacturer submits the HDE it must provide sufficient information in order for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury to the patient and that the probable benefits to health outweigh the risk of injury or illness from its use.

Physician Responsibilities for the Use of a HUD

A physician may utilize a HUD when agreeing to the following:

IRB Submission Requirements for Use of a HUD

Regardless of the intended use, a HUD requires prospective IRB review and approval by the Full Board. The use of a HUD does not constitute research unless the physician or health care provider intends to collect data from its use.

The physician must submit an IRB application for review at a convened meeting. Among other information, the physician must include the following in the application:

Instructions for submitting the initial application to the IRB are available in the Kuali Quickguide - Humanitarian Use Device.

Continuing Review Requirements

The physician is responsible for fulfilling Continuing Review requirements to the IRB at least annually. At the time of continuing review, the physician must report to the IRB in summary form each HUD activity at LSUNO or affiliated sites. This report must include the following:

Adverse Events and Unanticipated Problems

Adverse events and unanticipated problems that results from the use of a humanitarian device are subject to LSUNO IRB requirements for Reportable New Information.

FDA regulations require that if a physician or health care provider receives or otherwise becomes aware of information, from any source, that reasonably suggests that a HUD has or may have caused or contributed to the death or serious injury of a patient, the physician or health care provider must report such findings to the FDA as soon as possible, but no later than 10 working days after the Investigator first learns of the effect or problem. This reporting is in addition to, not a substitute for, FDA and/or manufacturer reporting requirements in accordance with 21 CFR 803.30.

The physician or health care provider is required to promptly report any FDA action(s) regarding the HUD to the IRB.

Amendments to the HUD

Changess to the HUD or the clinical use of the HUD are to be promptly reported to the LSUNO IRB in accordance with the IRB procedures for Amendments to approved research.