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Appendix K
USE OF FDA-APPROVED OR CLEARED DEVICES AND INVESTIGATIONAL DEVICES IN
CLINICAL RESEARCH STUDIES
Please read the applicable HRP webpage for information about the use of devices in clinical investigations.
This appendix is for studies that involve the use of FDA-approved or cleared devices and investigational devices
used in clinical research studies.
1. Identify the device(s) to be used in this study:
a. Device or Product Name:
b. Manufacturer:
2. Specify whether the device has FDA approval or is cleared for marketing [i.e., 510(k) exemption; or
Humanitarian Device Exemption (HDE)].
Yes - This device is approved for marketing in the U.S. and it is being used within its approved indication.
(skip questions 3-5)
Describe the approved indications for use of the device:
Yes - This is a 510(k) device and it is being used within its approved indication.
Note: Upload evidence of FDA 510k exemption with your IRB application (skip questions 3-5)
Describe the approved indications for use of the 510(k) device:
Yes - This is a Humanitarian Use Device (HUD) and it is being used within its approved indication.
Note: Include a copy of the FDA HDE exemption letter with your IRB.
(skip questions 3-5)
Provide the HDE number:
Describe the approved labeling and indications for use of the HUD:
No – Proceed to question #3
3. Does the device have an Investigational Device Exemption (IDE) Number?
Yes (answer question 4 and skip question 5 below)
No – If no, you must indicate why an IDE is not required: (skip question 4; answer question 5 below)
4. Provide the following information about the IDE:
a. IDE Number:
b. IDE Filing Date (mm/dd/yy):
c.
Holder of the IDE
Lead Researcher (Specify):
Study Sponsor
Other (Specify):
d. Does the IDE allow billing of subjects?
Yes
No
e. Provide a description of the device and any reports of prior investigations with the device.
f.
Provide the following information from the Investigator’s Brochure, package insert, or other materials
indicating where additional information about the device can be found. Also, upload the document(s) to
the e-IRB Application.
Section Title:
Page numbers:
g. Has another IRB determined that there is significant risk associated with this device?
Yes - include documentation from the IRB
No
5. Non-Significant Risk Determination:
Answer this question if:
 you are using an investigational device which does not have an Investigational Device Exemption (IDE)
number, and
 you believe the use of investigational device in this study poses non-significant risk.
A Significant Risk device is one that presents potential for serious risk to the health, safety, or welfare of a
subject and the device (1) is intended an implant; (2) is used in supporting or sustaining human life; (3) is of
substantial importance in diagnosing, curing, mitigating or treating disease, or prevents impairment of human
health; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. A
non-significant risk (NSR) device is one that does not pose significant risk.
Note: When assessing the risk of the device, consider the conditions for its use in the study, not just the
nature of the device itself.
In the space below, please explain why the use of the device in this study poses non-significant risk, and
attach any other supporting information (e.g., any reports of prior investigations). Please also explain whether
the FDA or any other IRB has determined the device to be significant or non-significant risk.
6. Provide the following information about how the device will be managed and controlled:
a. Describe your plan to ensure that the investigational device is used only in accordance with the UCI IRB
approved protocol:
b. Describe who will have access to the device and how access will be controlled to secure the device (or
device stock):
c.
Specify how records for control of the device (or device stock) will be recorded.
The sample Device Accountability Log on the HRPP website will be used.
The Device Log provided by the Sponsor will be used (be sure to attach this to the application).
No log will be used (specify why not):
d. Specify whether the investigational devices are manufactured in UCI research labs.
Yes (If yes, identify the lab):
No