Mother Frances Hospital Tyler
Institutional Review Board
irb@tmfhc.org / (903) 606-2472
Initial Review
Humanitarian Use Device
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients in the
treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000
individuals in the United States per year.
Most uses of HUDs are for treatment purposes, not for the purposes of a clinical investigation. In
these instances, the regulatory requirements for research of medical devices do not apply.
However, initial approval by full convened IRB and subsequent continuing review either by
expedited or full convened board review is required.
If your intended use of the HUD is for research purposes, all of the applicable regulations apply
and submission of a complete application including a fully-developed protocol and consent are
required.
Physician Sponsor:
Device:
Manufacturer:
Clinical department responsible for stocking:
Name of person completing this form:
Date:
Handwritten, copied or scanned versions of this form are not accepted. To prevent errors and
delays due to legibility problems, submit the original to irb@tmfhc.org . All questions must be
answered. Indicate NA for questions that are not applicable.
HUD staff
All HUD staff must complete the online human subject research training for Humanitarian Use
Devices offered through the Collaborative Institutional Training Initiative at the University of
Miami (CITI). www.citiprogram.org. Training is to be renewed every two years thereafter.
Physician sponsor:
Address:
Phone:
Email:
Complete for all HUD staff, providers, physicians, protocol coordinator, inventory coordinator
and others who have substantive interaction with patients (recruiting, obtaining consent,
evaluating response). Copy and paste table for each individual as needed. Each person listed
must complete and sign a Conflict of Interest statement.
Name:
Initial Review
Humanitarian Use Device
Last revised 09/03/2014
Page 1 of 4
Role:
Address:
Phone:
Email:
Device description
1. Describe the device and the procedure for using / inserting the device
2. List the U.S. Food and Drug Administration approved indications for the device
3. List the indications for which you anticipate use
Patient population
1. Describe the patient population for which you intend to use the device
2. Indicate the patient age range for the intended use of the device
3. Indicate the anticipated number of patients per year
4. Describe any patient screening procedures
5. Indicate the timeline for patient follow up visits, tests, procedures
Risks
1. Describe the known risks of the HUD (including non-physical risks) in detail and assess their
seriousness
2. Describe precautions taken to minimize risks
Informed consent / information
Initial Review
Humanitarian Use Device
Last revised 09/03/2014
Page 2 of 4
1. Obtaining consent (select one)
Informed consent will be obtained from all subjects and documented with a signed,
written consent form.
Informed consent will be obtained from subjects, but no signed consent form will be
used.
2. Indicate the location of the consent process (select all that apply):
In a private room
In a waiting room
In an open ward
In emergency situations (describe the process):
Over the phone (describe the process):
Other (specify locations and describe the process):
3. Information will be provided: (select one)
Prior to the use of the device
Following the use of the device (provide justification):
4. Information to be provided: (select all that apply)
Consent document
Manufacturer provided patient materials (list):
Other (describe):
Checklist
Indicate all documents included with this submission. Submit original (not scanned or copied)
forms, except for documents requesting signatures. All documents requesting signatures must be
completed, printed, signed and scanned. The U. S. Food and Drug Administration Listing of
Center for Devices and Radiological Health Humanitarian Device Exemptions website has
downloadable documents (link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm#2)
Conflict of Interest. A separate, signed document is required for all HUD staff
A copy of the HDE approval order
The HUD product labeling
Instruction for use manual
Protocol
Patient information packet from the manufacturer
Any other patient materials
List of providers that will use this device
Proof of completed training for insertion of device
Informed consent
Note: The HDE regulations, 21 CFR 814.126(a), require submission of Medical Device
Reporting (MDR) reports to FDA. Reports submitted to FDA must also be submitted to the IRB.
Initial Review
Humanitarian Use Device
Last revised 09/03/2014
Page 3 of 4
For additional information on HUDs:
 Guidance for HDE holders, Institutional Review Boards (IRBs), Clinical investigators,
and FDA staff – Humanitarian Device Exemption (HDE) regulations: Questions and
answers. Link:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/uc
m110194.htm
 U.S. Code of Federal Regulations, Title 21, Part 814, Subpart H- Humanitarian Use
Devices. Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814&
showFR=1&subpartNode=21:8.0.1.1.11.7
Initial Review
Humanitarian Use Device
Last revised 09/03/2014
Page 4 of 4