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HRPP Policy - Humanitarian use devices
About This Policy
- Effective date:
- Last updated:
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IU Human Subjects Office
This policy applies to clinicians under the oversight of the IU IRBs wishing to use a Humanitarian Use Device (HUD) for treatment or diagnosis, and the IU IRBs approving the use of the HUD.
This policy does not apply to clinical investigational use of a HUD (see Figure 1, Overview of regulatory procedures, referenced in FDA Guidance: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers; Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff). Use of a HUD is considered to be part of a clinical investigation if safety and effectiveness data will be collected on the HUD for the purpose of supporting a premarket approval (PMA) application. If use of a HUD is considered part of a clinical investigation, the use is considered research and research personnel must follow all policies and procedures applicable to human subjects research.
This policy does not apply to situations in which use of a HUD is necessary to save the life or protect the well-being of a patient and there is not sufficient time to request IRB approval (see Figure 1). In these situations, clinicians must follow the procedures outlined in the IU HRPP Policy on Emergency Use of Investigational Test Articles.Back to top
A HUD may only be administered in facilities under the oversight of an IRB acting in accordance with 21 CFR 56, including continuing review of the device, and only when use of the HUD has been approved by the IRB. In order to utilize a HUD for treatment or diagnosis, IRB approval must be obtained prior to use. Once approved, the HUD may be used only for the indications approved by the IRB.
In reviewing a request for HUD use, the IRB must consider the risks to patients as described in the product labeling, ensure the risks are minimized, and evaluate whether the risks are reasonable in relation to the proposed use of the device. The IRB has the discretion to approve use of the HUD for off-label indications given sufficient justification from the clinician(s).Back to top
The use of a HUD must be initially reviewed at a convened IRB meeting and approved before the device can be used. To facilitate initial review, the HUD application must be submitted via KC IRB, with the following documentation attached:
- The HUD manufacturer's product labeling, clinical brochure, and/or other pertinent manufacturer informational materials
- HUD manufacturer's patient information packet, if available, which should be provided to patients
- The FDA HDE approval letter
Research informed consent and authorization documents are not applicable and should not be submitted, as use of a HUD under this policy is not considered research.
All facilities which will utilize the HUD must be listed on the Protocol tab in KC IRB, and any clinician wishing to access the device must be listed on the Personnel Tab in KC IRB.
The IRB must conduct continuing review/renewal of the use of the HUD within the appropriate time frame as specified by the IRB at time of initial review, or use of the HUD must cease until such time that it can be reviewed. Renewal information must be submitted via KC IRB and review may be conducted via the expedited procedure.
Clinicians should track and report the following at the time of renewal:
- The number of patients who received the HUD for all clinicians listed on the protocol since the last review
- Summary of minor deviations and/or noncompliance since the last IRB review
- Statement whether adverse events have occurred in excess of the expected frequency and level of severity as documented in the HUD manufacturer's product labeling, clinical brochure, and/or other pertinent manufacturer informational materials
- Summary of actual benefits experienced by enrolled HDE patients
- Any relevant information, published or unpublished, since the last IRB review, that may impact patient safety or continued use of the HUD, especially information about the risks associated with the HUD. Relevant information may include literature publications, audits, patient complaints, or interim findings.
If modifications to the initial IRB approval are needed to allow for additional indications, either FDA-approved or justified by the clinicians, the clinician(s) should submit an amendment to the existing protocol via KC IRB describing the modifications and the rationale.
Reportable Events must be reported to and reviewed by the IRB in accordance with the IU HRPP Policy on Reportable Events.
Individuals found to be in violation of this policy may be subject to sanctions related to the clinical use of the HUD at Indiana University's affiliates, including withdrawal of IRB approval.Back to top
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
adverse event Any untoward or unfavorable occurrence, including medical, physical, and psychological harms, in a human subject associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
audit (see also for-cause (directed) audit, internal audit, and not-for-cause (scheduled) audit) A systematic and independent examination of study-related activities and documents to determine whether the evaluated study-related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to applicable federal regulations, state laws, and institutional policies. Includes audits, monitoring visits, and compliance inspections.
authorization Per the Privacy Rule, an individual's permission to allow a covered entity to use or disclose the individual's protected health information (PHI) described in the authorization for the purpose(s) and to the recipient(s) stated in the authorization.
clinical investigation (FDA) (see also research) For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).
device (medical device) As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3) intended to affect the structure or any function of the body of man or other animals, and; which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
humanitarian device exemption (HDE) FDA marketing application for a HUD.
humanitarian use device (HUD) As regulated by the FDA, "a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year."
investigator (FDA, see also research personnel, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
noncompliance (see also continuing noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.05, or institutional policies governing human subjects research or the requirements or determinations of the IRB.
reportable event An event which may represent noncompliance or an unanticipated problem involving risks to subjects or others. Reportable events are reported to the IRB in accordance with the IU HRPP Policy on Reportable Events.Back to top