Policy
Use of a Humanitarian Use Device (HUD) for treatment, diagnosis or research must receive both Food and Drug Administration (FDA) and Institutional Review Board (IRB) approval.
The FDA must issue a Humanitarian Device Exemption (HDE) prior to IRB approval. Initial review of an HUD must be completed by a convened IRB (full board review). The IRB may approve the use of the HUD without further restrictions,approve on a case by case basis, or require a protocol for use in the case of research. The IRB may impose more stringent restrictions for the use of the HUD in order to provide additional protections as deemed necessary.
Unless informed consent is specifically waived by the IRB, the use of an HUD will require documented, written informed consent from each patient or their legally authorized representative prior to its use, regardless of whether the HUD is being used in the course of clinical treatment or in a research study. In addition, the project lead or delegated personnel must provide the patient with the HUD brochure (prepared by the manufacturer) if available and review with patient prior to use.
The convened Board may determine that future review may occur using the expedited procedure as long as the HUD is not being used in the course of research. Continuing review of the HUD is required no more than every 365 days or as determined by the IRB.
Lead physician must ensure compliance with all applicable federal regulations and IRB requirements pertaining to it use.
Definitions
Humanitarian Device Exemption (HDE) – Food and Drug Administration (FDA) approval for a physician to use an HUD in a clinical treatment or in a clinical investigation. An approved HDE authorizes marketing of an HUD.
Humanitarian Use Device (HUD) – a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United Sates per year.
Lead Physician – Physician assuming responsibility for local oversight of use and compliance with Federal regulations and IRB requirements.
Procedure
The following documentation, as applicable, must be submitted to the IRB for initial review:
IRB application, to include the following:
The generic and trade name of the device
Name of Manufacturer
The FDA holder HDE number
Copy of FDA letter with date of HDE designation
Indications for use of the device
A description of the device
Contraindications, warnings and precautions for use of the device
Adverse effects of the device on health
Alternative practices and procedures
The HUD Brochure or materials that have been developed by the manufacturer for the patient’s use (i.e. patient packet)
Marketing history
Summary of studies using the device, if any
Other information as provided by the manufacturer
Effectiveness of the HUD does not have to be demonstrated, however, the IRB will verify that the device does not pose an unreasonable risk of illness or injury to the recipient, and the probable risks and benefits of currently available devices or alternative forms of treatment.
Unless the HUD will be used in a research study, IRB will approve use of the HUD for its FDA approved indication only.
Both the product labeling and the informed consent must state the device is an HUD and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been proven or demonstrated.
Any modification(s) to the HUD, clinical use or research study are to be submitted to the IRB for approval (See Modification (Amendment), Sponsor Waivers or Exceptions-IRB Review of Changes Policy).
Use of an HUD in Research –
Data collected for safety and effectiveness about the device, if the use is within the approved labeling, does not require an IDE. IRB approval is required and written informed consent must be obtained, as this constitutes research.
Collection of data for a new useof the device requires the Investigational Device Exemption (IDE) regulations to be followed, as thisconstitutes research. IRB approval is required, written informed consent must be obtained and continuing review must be by the convened IRB.
Compassionate (Expanded Use) –
An HUD may, for certain indications, be used for clinical care after obtaining FDA and IRB approval. Compliance with FDA expanded access (compassionate use) policy for unapproved devices is required.
Off-Label Use -
Off label use of an HUD may be permitted, if the following conditions are met:
Patient’s life is threatened or there is risk of serious harm
No generally accepted alternative exists
If there is time to obtain IRB/FDA approval (i.e. expanded or compassionate use) for an off-label use, the following must be submitted for IRB consideration:
Patients initials and date of birth
Anticipated date of device use
Reason for the use
FDA approval letter
Independent assessment by an uninvolved physician
Concurrence of the IRB chair or designated board member
Approval by the institution
Informed consent by the patient or legally authorized representative
Authorization by the HDE holder (usually the manufacturer) or the IDE sponsor if an IDE exists.
If the lead or other approved physician determines IRB approval cannot be obtained in time to prevent serious harm or death to a patient, the HUD may be used without prior approval.
Within 5 working days of the emergency use, the lead physician or other approved physician must provide written notification to the IRB of such use to include at a minimum the following information:
Patients initials and date of birth
Date device was used
Reason for the use
Independent assessment by an uninvolved physician
Status/outcome of patient
Unanticipated Problem/Adverse Event –
Patients receiving an HUD must be followed for Unanticipated Problems/Adverse Events as required by the device manufacturer, FDA or for a minimum of 30 days, whichever is longer.
If the lead physician or other health care provider receives or becomes aware of information from any source, at any time, that reasonably suggests that an HUD has or may have caused or contributed to the death or serious injury of a patient, such information must be reported to the manufacturer, FDA and IRB. IRB reporting is required within 5 days of gaining knowledge of the event (See Unanticipated Problem/Adverse Event SOP).
Other –
IRB reporting is in addition to, not a substitute for FDA and/or manufacturer reporting requirements in accordance with 21 CFR 803.30.
The lead physician must promptly report any FDA action(s) regarding the HUD to the IRB.
Version date 10-2015Page 1 of 3