The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “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.” Because the research has shown a HUD to have only “probable benefit,” rather than “a reasonable assurance of effectiveness,” every HUD requires IRB approval and oversight, whether for use in clinical care or in research.
- Before submitting an IRBMED application, determine which of the following applies:
- A HUD will be used for clinical care (HUD Use);
- Safety and effectiveness data will be collected for the approved use; or
- The HUD will be studied for a new indication.
The first two uses are covered under an FDA-issued Humanitarian Device Exemption (HDE). In most instances, the device’s manufacturer holds the HDE. Occasionally, the UM or other physician is the HDE holder.
The third use requires an Investigational Device Exemption (IDE). An IDE may be issued either by the IRBMED or by the FDA, depending on the risk level associated with the use. The sponsor (whether physician/investigator, manufacturer, or other party) holds an IDE to conduct clinical research designed to determine the appropriateness of the device for a new indication.
- Obtain the HDE number or, if the FDA has granted an IDE, the IDE number.
- Follow the steps corresponding to the type of HUD use that you are planning:
- On-label use without collection of safety and effectiveness data (HUD Use)
- On-label use with collection of safety and effectiveness (HUD Clinical Investigation)
- Emergency or off-label use of a HUD approved for use at UM
- Emergency use of a HUD for which no UM IRB-approved project exists
- Use of a HUD in a clinical investigation designed to determine a device’s suitability for a new indication
- See below for required reporting in HUD clinical care (HUD under an HDE, not an IDE):
- On the second page of the eResearch application, in box 1-1.2, select Humanitarian Use Device (HUD) under an HDE.
- eResearch will route you to the required sections. Click here for a screenshot showing the main section of the HUD application. Include the following in your responses:
- A summary of your proposed use of the device (box 1.8)
- The identity of the HDE holder (If you hold the HDE, state this in box 1.8; otherwise, include it within the documentation uploaded in 1-5.12.)
- Any patient follow-up visits, tests, or other procedures (box 1.8; upload further documentation in 1-5.12.)
- Any screening procedures (boxes 1.8, 1-5.3 and 1-5.7)
- A description of the HUD procedure itself (boxes 1.8, 1-5.5, and 1-5.6)
- A copy of the HDE approval order (Upload this in 1-5.12.)
- The product labeling (1-5.3 and 1-5.5, as applicable; if available electronically, explain in text fields and upload documentation in 1-5.12.)
- The patient information packet that may accompany the HUD (Upload this in 1-5.12.)
- The IRBMED-recommended HUD informed consent template (Upload this in 1-5.13.)
- Submit the eResearch application and await IRBMED approval.
- After receiving notification of IRBMED approval, you may administer the HUD, according to its approved labeling, without obtaining IRBMED approval for each use. When the device is used off-label or used in an emergency, report the use to the IRB within 7 calendar days.
- Report to the manufacturer and/or FDA, as required.
- Submit to the IRBMED all required reports.
Submit to the IRBMED an annual renewal application prior to project expiration.
Once you have determined that you will no longer use the HUD at UM, submit an IRBMED termination application.
If safety and effectiveness data will support a Premarket Approval (PMA) application, the FDA requires you to follow some standard research regulations, with the exception that no IDE is needed. Complete a standard IRBMED eResearch application, using the standard informed consent template for research studies. You may, however, follow the reporting guidance below, rather than standard reporting requirements.
- Apply consent and patient-protection measures, as required by the FDA.
- IRBMED does not require the investigator to obtain IRB permission ahead of time to use a HUD off-label. However, FDA recommends that the user submit to the HDE holder follow-up information on the patient’s condition following the use. IRBMED requires that this report also be submitted to IRBMED as an ORIO at the same time it is sent to the HDE holder. Also, the investigator is required to submit any adverse events reports to IRBMED as required by the FDA.
- Submit to the HDE holder follow-up reports, as required by the HDE holder and recommended by the FDA.
If IRBMED has not yet approved a HUD’s use at UM, follow FDA regulations for emergency use of an unapproved device. You must also follow any UMHS requirements for devices used on patients.
Within 5 calendar days of use of the device, submit to the IRBMED an Emergency Use Report in eResearch.
- On the second page of the eResearch application, in box 1-1.2, select Emergency one-time use of an investigational or unapproved device.
- eResearch will route you to the required sections. Click here for a screenshot showing the main emergency use section.
- Use the IRBMED-recommended emergency use informed consent document, available from the IRBMED office.
- If the UM physician holds the HDE, indicate this in the application.
- Report to the manufacturer and/or FDA, as required.
- Submit all other reports to the IRBMED, as required.
Complete a standard IRBMED eResearch application, observing all applicable UM research policies. This type of study falls under the IDE requirement. If the sponsor identifies the proposed use of the device to be non-significant risk, the IRBMED can grant an IDE. If the proposed use of the device is deemed to be significant risk (see definition in 21 CFR 812.3[m]), an IDE from the FDA is required. Generally, all off-label uses of a HUD have been designated as significant risk.
(HUD under an HDE, not an IDE)
Within 14 calendar days, UM and/or the HDE holder must submit to both the FDA and the IRBMED a Medical Device Report (MDR), informing them of one or both of the following events:
- The HUD appears to have caused or contributed to death or serious injury.
- The HUD appears to have malfunctioned and is likely to cause or contribute to death or serious injury should the malfunction recur.
FDA defines a serious injury as one that:
- is life-threatening;
- results in permanent impairment of a body function;
- results in permanent damage to a body structure;
- necessitates medical or surgical intervention to preclude permanent impairment of a body function; or
- necessitates medical or surgical intervention to preclude permanent damage to a body structure.
When reporting the event, use the eResearch UM Serious Adverse Event form.
Prior to submitting any reports from the FDA, contact the IRBMED (763-4768) and/or the Health System Legal Office (764-2178). Also, provide the IRBMED with copies of all FDA correspondence, as noted below.
Use the ORIO form entitled “Report to or from an Oversight Entity” to report the following (click here to view a blank report):
- Within 7 calendar days of mailing any reports to the FDA, submit copies to the IRBMED.
- Within 7 calendar days of receiving any reports from the FDA, submit copies to the IRBMED.
- Within 7 calendar days of receiving from the sponsor/manufacturer/HDE holder any reports regarding urgent safety concerns or calling for changes in the use of the device, submit copies to the IRBMED.
- Within 7 calendar days of submitting to the sponsor/manufacturer/HDE holder any follow-up or other reports, submit copies to the IRBMED.
- When applying for approval of continuing review, submit to the IRBMED any routine reports to or from the sponsor/manufacturer that do not involve urgent safety concerns or call for changes in the use of the device.
Should you identify a breach of confidentiality, report it immediately to the UMHS Privacy Office (615-4759).
- Within 7 calendar days of identifying the breach, submit a report to the IRBMED. Use the ORIO form entitled “Protocol Deviation” (click here to view a blank report).
Web page created 2/7/2013