UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

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IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Humanitarian Use Device Requirements for UM Physicians and Investigators

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.

Prior to submitting an IRB application:

• Ascertain whether an FDA-issued Humanitarian Device Exemption (HDE) or Investigational Device Exemption (IDE) covers the use.
• In most instances, the device’s manufacturer holds the HDE. Occasionally, the UM or other physician is the HDE holder.
• The sponsor (whether physician/investigator, manufacturer, or other party) holds an IDE to conduct clinical research aimed to determine the appropriateness of the device for a new indication.
• Obtain the HDE or IDE number.
• If the device is under an HDE, ask the HDE holder whether patient safety and effectiveness data collected at this institution will serve to support a premarket approval (PMA) application to be submitted to the FDA.

Using the information gathered or the particular situation at hand, follow the steps required for UM use, depending on its nature:

• On-label use without collection of safety and effectiveness data to support a premarket approval (PMA).
• On-label use with collection of safety and effectiveness data to support a premarket approval (PMA).
• 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.

 

On-label use of a HUD in clinical care, without collection of safety and effectiveness data.

• Submit an eResearch application and await notification of IRBMED approval.
• On page two of the application, in box 1-1.2, select Humanitarian Use Device (HUD) under an HDE.  
• The application 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 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 in 1-5.12).
• The IRBMED-recommended HUD informed consent template (upload in 1-5.13).

• After receiving notification of IRBMED approval, you may administer the HUD, according to its approved labeling, without obtaining IRB 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 (see below).
• Report to the manufacturer and/or FDA, as required.
• Submit to the IRBMED all required reports (see below).
• Submit to the IRBMED a renewal application prior to project expiration. Once you have determined that you will no longer use the HUD at UM, submit an IRB termination application.

 

On-label use of a HUD in clinical care with collection of safety and effectiveness data to support a PMA.

If safety and effectiveness data will support a PMA application, the FDA requires you to follow standard research regulations. This is true even when the HUD is used under an HDE. Complete a standard IRB eResearch application, using the standard informed consent template for research studies. You may, however, follow the reporting guidance below, rather than standard reporting requirements.

 

Emergency or off-label use of a HUD approved for use at UM.

• Apply consent and patient-protection measures, as required by the FDA (see question #66).
• Within 7 calendar days of use of the device, complete and submit to the IRB the ORIO form entitled “Report from or to and Oversight Entity.” This form will be what is termed a child submission under the eResearch parent project relating to UM use of the HUD. Click here to view a blank report.
•  If you are not the physician named as the principal investigator (PI) on the HUD project, contact the PI’s team and instruct them to complete and submit the ORIO report within the 7 day period. Retain documentation of when you provided the information to the PI’s team. If the PI is unavailable to submit the ORIO, contact the IRBMED office. It is your responsibility to supply all information necessary to provide the PI’s team with sufficient time to prepare and submit the required report.
• Submit to the HDE holder follow-up reports, as required by the HDE holder.
• The IRBMED also must receive copies of these reports. If available in time, they may accompany the ORIO informing the IRB of use of the device.
• Submit to the IRBMED all other reports, as required (see below).

 

Emergency use of a HUD for which no UM, IRB approved project exists.

If the 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 eResearch Emergency Use Report.

• On the second page of the application, in box 1-1.2, select Emergency one-time use of an investigational or unapproved device.
• The application 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.
• If the UM physicianholds 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 (see below).

 

Use of a HUD in a clinical investigation testing a prospective new indication.
Complete a standard IRB eResearch application, observing all applicable UM research policies.These are studies that fall under an IDE.

 

Required Reporting in HUD Clinical Care (HUD under an HDE, not an IDE)

ADVERSE EVENTS
Within 7 calendar days, UM and/or the HDE holder must submit reports to both the FDA and the IRBMED, of one or more 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.
• 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.

OTHER REPORTABLE INFORMATION AND OCCURENCES (ORIO)
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 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 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.

 

8/20/09