Humanitarian Use Devices

Overview

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:

• The HUD will be utilized for treatment, diagnosis, or research in accordance with the labeling of the device, intended purpose, and in the designated population for which the FDA approved its use;
• The patient must be informed that the HUD is a device authorized under Federal law for use; however, the effectiveness of the device for a specific indication has not been demonstrated; and
• The informed consent of the patient or the patient’s legally authorized representative will be obtained when the use of the HUD involves research or when required by the IRB.
• The UCI IRB generally requires that treating physicians obtain informed consent. A HUD Informed Consent form template has been developed for use.
• HIPAA Research Authorization is not required unless the IRB has access to protected health information as part of their review process (unusual at UCI).
• The California Bill of Rights is not required.

IRB Submission Requirements for Use of a HUD

Regardless of the intended use, a HUD requires prospective IRB review and approval by the full Committee.

The physician must submit an IRB application via Kuali Research (KR) Protocols for review at a convened meeting. The physician must include the following information in the application:

• The generic and trade name of the device;
• The FDA HDE number;
• The date of HUD designation;
• The indications for use of the device;
• A description of the device;
• Contradictions, warning, and precautions for use of the device;
• Adverse effects of the device on health;
• Alternative procedures;
• Marketing history;
• A summary of studies using the device; and,
• The HUD brochure.

Renewal Requirements

The physician is responsible to submit a renewal application to the IRB at least annually. The physician must report the HUD activities for the previous 6 months for all non-UCI performance sites. In addition, the following information must be provided to the IRB in summary form for each HUD at UCI or affiliated sites. This report must include the following:

• The clinical indications for the use of the HUD in each patient;
• Clinical outcomes of each participant, if known.

Amendments to the HUD

Amendments to the HUD or the clinical use of the HUD are to be promptly submitted to the UCI IRB in accordance with IRB policy.

Adverse Events and Unanticipated Problems

Adverse events and unanticipated problems that results from the use of a humanitarian device are subject to UCI IRB Unanticipated Problems reporting requirements.

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.

Emergency Use of a HUD

Off-label use of a HUD in an emergency situation that cannot wait for IRB review and approval may be handled under the Emergency Use of an Unapproved Drug, Biologic or Device provision provided that the situation meets the FDA criteria under 21 CFR 56.104 (d) and the HUD is used not used outside its approved labeling.