Yale University Institutional Review Boards
Yale New Haven Hospital
HUMANITARIAN USE DEVICE APPLICATION
610 FR.1-1 (2015-1)
Initial Request: ________________ Renewal Request: __________
Per FDA regulation 21 CFR 814.124(a), the HUD Application must be completed before
initiating use of an HUD, and annually thereafter. This application is to be submitted as a
supplement to the manufacturer’s materials delineated in Section IX.
If this is a renewal request, complete the Contact Information below and Sections I and XI only.
HIC Protocol Number:
Title of Project:
Contact Information:
Principal Responsible Physician:___________________________________
Department:_____________________________________________________
Campus Address:_________________________________________________
Email Address:___________________________________________________
Telephone Number:________________________________________________
I.
Device Information
Humanitarian Use Device Name:__________________________________
Manufacturer:__________________________________________________
FDA Humanitarian Device Exemption (HDE) Identifier Number:_____________
II.
YNHH Information
1. Are there any investigational devices used or investigational procedures performed at Yale-
New Haven Hospital (YNHH) (e.g., in the YNHH Operating Room or YNHH Heart and
Vascular Center)? ☐Yes ☐No If Yes, please be aware of the following requirements:
a.
A YNHH New Product/Trial Request Form must be completed via EPIC: Pull down the
Tools tab in the EPIC Banner, Click on Lawson, Click on “Add new” under the New
Technology Request Summary and fill out the forms requested including the “Initial
Request Form,” “Clinical Evidence Summary, “ and attach any other pertinent
documents. Then select “save and submit” to submit your request; and
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a. Your request must be reviewed and approved in writing by the appropriate YNHH
committee before patients/subjects may be scheduled to receive the investigational device
or investigational procedure.
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at
the HRU, the Principal Investigator and any co-investigators who are physicians or mid-level
practitioners (includes PAs, APRNs, psychologists and speech pathologists) who may have
direct patient contact with patients on YNHH premises must have medical staff appointment and
appropriate clinical privileges at YNHH. If you are uncertain whether the study personnel meet
the criteria, please telephone the Physician Services Department at 203-688-2615. By signing
this protocol as a PI, you attest that you and any co-investigator who may have patient contact
has a medical staff appointment and appropriate clinical privileges at YNHH.
III.
Background: (Describe the device that qualifies as an HUD, the condition/disease that
indicates the need for an HUD, and the indication approved by the FDA for use of the
device. Include information on previous use.)
IV.
Use Request: (Describe the eligibility criteria, usual treatment history for a patient
who would qualify for use of an HUD, the reason use of the HUD is worth the risk to
the patient at this time, and the procedures and methods that the patient(s) will
undergo.)
Consent (Describe the process of clinical consent for the procedure: personnel
obtaining consent, assessment of the patient’s capacity to consent, conditions under
which consent will be obtained, any steps to minimize undue influence and any steps to
enhance the patient’s independent decision-making, such as a waiting period. If nonEnglish-speaking patients are to receive the device, describe provisions in place to
assure comprehension. If the patient is a minor, describe how parental or guardian
permission will be obtained)
V.
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VI.
Unanticipated Problems Involving Risk to Patients or Others:
NOTE: The following unanticipated problems must be reported to the HIC within 48
hours of becoming known to the physician:
a. Problems or events that are unexpected (in terms of nature, severity, or
frequency) given the HUD procedures and the characteristics of the patient
population;
b. Problems or events that suggest that the HUD places the patient at greater risk
or harm (including physical, psychological, economic, or social harm) than was
previously known or recognized; and
c. Problems or events that are related or possibly related to the patient’s receipt of
the HUD.
(Describe who will be responsible for monitoring patient safety and reporting
unanticipated problems.)
VII.
Financial Considerations: Will the patient incur any financial obligation as a result of
receiving this device?
VIII. Personnel: (All personnel who will be administering the HUD must be listed below,
with their affiliation [Yale New Haven Hospital, Yale University], and attestation
regarding Conflict of Interest.)
Name
Affiliation
Principal
Physician
Physician
Physician
Physician
Physician
Conflict of Interest:
For Yale University Faculty: If you, your spouse, domestic partner or any dependent
children have any stock or patent position with the device company, have participated in
the product design or development of this device, have received compensation from this
company or serve as a director or consultant to this company, you must complete an
annual External Interests Disclosure Form. This form can be found at
http://www.yale.edu/coi/
List the name(s) of the faculty member(s) who have such interests:
_________________________________________________________
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For non-Yale Faculty, please consult with the Yale-New Haven Hospital Human Subject
Protection Administrator (HSPA) for YNHH requirements regarding conflict of interest
disclosure.
IX.
Attestation
I certify that the information provided in this request is complete and accurate. I
agree to:
 perform the procedure as outlined herein and approved by the IRB;
 use the device only as described on the FDA approved label
 provide the patient with appropriate information to make an informed
decision about the use of the device
 report unanticipated problems involving risk to patients to the IRB
according to IRB procedures
 notify the patient of any new findings regarding the device
I certify that the HUD is not being used as part of a research project or clinical
investigation designed to collect data to support an FDA pre-marketing approval
application.
X.
___________________________________
____________
Signature
Date
Enclosures: (The following materials must be submitted with the application)
___Sponsor’s Clinical brochure, protocol, or other pertinent informational
materials
___Patient information booklet—from the Sponsor
___Other relevant documents (e.g., package insert)
_____________________________________________________________________________
XI.
Annual Renewal
A. How many times has the device been used in the past year?
B. Describe any unanticipated problems occurring in the past year.
Were these problems reported to the HIC? (Give date of report.)
C. Has there been any change in the FDA approval status of the device?
Yes ___ No ___ (If yes, describe)
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D. Are there any changes to personnel?
Yes ___ No ___
(If yes, new personnel must complete the information below)
Name
Affiliation
Principal
Physician
Physician
Physician
Physician
Physician
E. Principal Physician Attestation
I certify that the information provided in this request is complete and accurate. I
agree to:
 perform the procedure as outlined herein and approved by the IRB;
 use the device only as described on the FDA approved label
 provide the patient with appropriate information to make an informed
decision about the use of the device
 report unanticipated problems involving risk to patients to the IRB
according to IRB procedures
I certify that the HUD is not being used as part of a research project or clinical
investigation designed to collect data to support an FDA pre-marketing approval
application.
___________________________________
____________
Signature
Date
For HIC Use Only
Date Approved
Human Investigation Committee Signature
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