UNIVERSITY OF MINNESOTA
INSTITUTIONAL REVIEW BOARD
Appendix F
Use of Devices in Research
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Researchers planning to include devices in research projects must complete this form.
Research involving devices is typically not eligible for expedited review.
The Investigational Device Exemption (IDE) Regulations describe two types of device studies: “significant risk”
(SR) and “non-significant risk” (NSR). (See 21 CFR 812 and FDA Information Sheet on Medical Devices.) The
IRB is required to document the basis for risk determination based on the proposed use of a device in the research
by considering the nature of the harm that may result from the use of the device. FDA has the ultimate decision in
determining SR and NSR.
1. Identify the device(s):
Name of Device
Manufacturer
Device Model:
Indications or Use:
Is this device lawfully marketed in the US for human use?
If yes, provide PMA or 510 (k) number:
Is the device to be used in this study used for the same indications
as the marketed device?
Yes
No
Yes
No
2. Device information:
Attach brochure or information from the manufacturer describing the device.
3. Significant Risk (SR) and Non-Significant Risk (NSR) Assessment:
A. Has the investigational device holder/regulatory sponsor made a risk assessment?
No
Yes: Check applicable risk assessment below. Attach documentation that includes sponsor’s risk
assessment report for the investigational use of this device. If another IRB has determined the
device to be Significant Risk, attach documentation of this determination for UMN IRB review.
Significant Risk (IDE application submitted to FDA. Comply with full requirements)
Non-significant Risk (IDE application NOT submitted to FDA. Comply with abbreviated
requirements)
B. Respond to the following questions regarding use of the device in this study:
Is the device intended as an implant?
Is the device to be used in supporting or sustaining human life?
Is the device to be used in diagnosing, curing, mitigating or treating disease,
or preventing impairment of human health?
Will a subject need to undergo an additional procedure as part of the
investigational study?
Does the device otherwise present a potential for serious risk to the health,
safety or welfare of a subject?
Yes
Yes
No
No
Yes
No
Yes
No
Yes
No
C. If all answers in section 3B are no, the device is NSR. (Skip to section 3D if any answers in 3B were yes.)
Respond to the following questions regarding the NSR device:
Updated November 2012
Use of Devices in Research – Appendix F
UNIVERSITY OF MINNESOTA
INSTITUTIONAL REVIEW BOARD
Note: FDA considers an IDE to be in effect for NSR devices; however, there is no IDE number. The
researcher must comply with abbreviated IDE requirements at 21CFR812.2 (b).
a) Provide investigator’s rationale for the non-significant risk assessment:
b) Who holds the IDE for this NSR device?
Investigator
Manufacturer
Other
D. If any answer in section 3B is yes, the device is SR and an IDE # from the FDA is required. Respond to
the following questions regarding the SR device:
a) Provide the IDE #:
b) Who holds the IDE for this SR device?
Investigator: Investigator-initiated study: Attach a protocol that meets GCP guidelines.
A protocol template for devices is available at http://www.ctsi.umn.edu/
Manufacturer
Other
Note: If this is an investigator-initiated study, the investigator is the IDE holder and the investigator
is also considered the regulatory sponsor.
4. Federal regulations require the controlled use of experimental devices. Please
describe the mechanism you will use to label, store and dispense the inventory of
investigational devices and confirm you will comply with the University Policy on
Reporting Sponsor-Investigator INDs or IDEs:
http://www.policy.umn.edu/Policies/Research/INDIDE.html:
5. For all studies that are registered with ClinicalTrials.gov:
ClinicalTrials.gov Identifier:
(List all that apply)
NCT#
Updated November 2012
Use of Devices in Research – Appendix F