UNIVERSITY OF MINNESOTA
PI Name:
INSTITUTIONAL REVIEW BOARD
Date: Click here to enter a date.
Project title or IRB #:
Appendix F – Use of an Approved or Investigational Medical
Device in Research
Instructions for completing this form:
 Researchers planning to include a medical device not legally distributed in the United States interstate
commerce, even if the research question is not about this device, must complete this form.
 Researchers planning to include a commercial medical device that is studied for a new indication, new
patient population, device enhancements or other modifications, must complete this form.
 This form does not apply to medical devices that are legally distributed in the United States interstate
commerce and are used identically to their corresponding Instructions for Use and Labeling except if you
are investigating the device for safety and effectiveness (the device is the subject of your research).
 Notwithstanding the above provisions, the IRB may request Appendix F if more information about the
device is needed to aid in its evaluation of human subjects’ research.
 Complete a separate Appendix F for each medical device.
 See 21 CFR 812 for regulations governing use of investigational medical devices
 For questions about this form please contact the HRPP office at medreg@umn.edu
Device Identification
Name of Device
Manufacturer
Device Model:
Include software version and accessories if
Indications or Use:
applicable
Provide the weblink to the manufacturer’s product description:
Please provide the link to the page on which the manufacturer describes the product, not just the
manufacturer’s home page.
Section 1 Use of an Investigational Medical Device
All information below must be provided with this Appendix F. Provide the information below or Indicate in
which accompanying document the information requested may be found.
1.1 Is this device approved or cleared for a different indication?
Yes. If yes, provide the FDA PMA, HDE or 510(k) #
No
1.2 Is this a combination product as defined by FDA 21 CFR 3.2(e)?
No
Yes If yes, provide any information about the device or the FDA determination that will aid the IRB in review
of application
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1.3. Provide a detailed device description, including a photographs or diagrams with explanation of critical
components, and identification of materials used. Include details of any medicinal products, human or animal
tissues or their derivatives or other biologically active substances if applicable.
or
Indicate section/page number of protocol/application:
See attachment labeled:
1.4 Provide draft instructions for use (IFU), system reference guide or manual of operations for this indication.
The IFU must include any necessary storage and handling requirements, preparation for use and eventual
intended reuse (e.g. sterilization), any pre-use checks of safety and performance and any precautions to be taken
after use, e.g. disposal.
or
Indicate section/page number of protocol/application:
See attachment labeled:
1.5 Provide a summary of necessary training and experience needed for the use of the device to be
investigated.
or
Indicate section/page number of protocol/application:
See attachment labeled:
1.6 Provide a description of necessary medical or surgical procedure involved in the use of the device.
or
Indicate section/page number of protocol/application:
See attachment labeled:
1.7 Provide information regarding how device risks are minimized
or
Indicate section/page number of protocol/application:
See attachment labeled:
1.8 Provide a description of preclinical testing or published articles with a justification why the next step is
testing on human subjects for this indication
or
Indicate section/page number of protocol/application:
See attachment labeled:
1.7 Identify who is responsible for record keeping of the investigational product’s delivery to the trial site, the
inventory at the site, the use by each participant, and the return to the sponsor or alternative disposition of
unused products.
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These records must include: Dates, Quantities, Lot/serial numbers, Expiration dates (if applicable), Unique code
numbers assigned to the investigational products and trial participants
Section 2 Investigational Device Exemption Status
2.1 Has an IDE number been assigned?
No. Go to question 2.2
Yes.
Provide the IDE number
Who Is the sponsor (holder)?
Validation of IDE number is required. Provide the following with your application:
Written communication from the FDA
Sponsor protocol imprinted with IDE number
If an IDE number has been assigned DO NOT complete section 3 or section 4. Section 5 – Special Considerations
for Investigator Initiated Research is required.
2.2 Is an application pending with the FDA for IDE Number?
No. Go to Section 3 - IDE exemption
Yes.
Who submitted/will hold (sponsor) the IDE?
Expected date of IDE documentation?
Note: Final approval will not be granted until documentation of
IDE number is provided.
If an IDE number is pending, DO NOT complete section 3 or section 4.
Section 5 – Special Considerations for Investigator Initiated Research is required.
Section 3 IDE Exemption Determination
If an IDE number is neither assigned nor pending, indicate if any category of IDE exemption is met. If at
least one of the categories is met, the device is considered IDE exempt
Determine the category of exemption that applies to the device used in the proposed research project
Category 1
A. The device was regulated as a drug before
enactment of the Medical Device
Amendments (transitional device)
Yes – Not eligible for Cat 1 exemption
No
B. The device is FDA-approved/cleared.
Yes, provide the PMA or 510K#:
No - Not eligible for Cat 1 exemption
C. The device is being used/investigated in
accordance with the indications on the FDA
approved/cleared labeling.
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Appendix F – Use of Devices
Yes
No– Not eligible for Cat 1 exemption
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If no to question A and yes questions B and C, the device is exempt. Complete Section 5 - Special
Considerations for Sponsor Investigator.
If the device is not eligible for Category 1 exemption, complete the Category 2 assessment below.
Category 2
A. The device is a diagnostic device.
Yes
No– Not eligible for Cat 2 exemption
B. The sponsor will comply with applicable
requirements of 21CFR809.10(c).
Yes
No– Not eligible for Cat 2 exemption
C. The testing is non-invasive.
Yes
No– Not eligible for Cat 2 exemption
D. The testing does not require an invasive
sampling procedure that presents significant
risk
Yes
No– Not eligible for Cat 2 exemption
E. The testing does not, by design or
intention, introduce energy into a subject.
Yes
No– Not eligible for Cat 2 exemption
F. The testing is not used as a diagnostic
procedure without confirmation of the
diagnosis by another medically established
diagnostic product or procedure
Yes
No– Not eligible for Cat 2 exemption
If yes to all category 2 statements A-F – device is exempt. Complete Section 5 - Special Considerations for
Sponsor Investigator.
If the device is not eligible for Category 1 or 2 exemption, complete the Category 3 assessment below.
Category 3
A. The device is undergoing consumer
preference testing, testing of a modification or
testing of a combination of two or more
devices in commercial distribution, and the
testing is NOT for the purpose of determining
safety or effectiveness and does not put
subjects at risk.
Yes
No– Not eligible for Cat 3 exemption
If yes to category 3 statement A, the device is exempt. Go directly to Section 5 - Special Considerations for
Sponsor Investigator.
If no exemption categories apply, complete Section 4 Risk Assessment
Section 4 Risk Assessment
Answer the questions below to determine if the device is Significant Risk (SR) or Non-Significant Risk
(NSR)
Is the device intended as an implant?
Yes
No
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Is the device to be used in supporting or sustaining human life?
Yes
No
Is the device to be used in diagnosing, curing, mitigating or treating disease, or
preventing impairment of human health?
Yes
No
Will a subject need to undergo an additional procedure as part of the investigational
study?
Yes
No
Does the device otherwise present a potential for serious risk to the health, safety
or welfare of a subject?
Yes
No
Describe the possible risks associated with the device as used in this study in relation to potential
benefits to subjects (include only additional risks to those listed in Section 3 of the IRB application):
If NO to all questions in Risk Assessment section above Device may be non-significant risk
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 21CFR812.1(b).
If YES to any question in the Risk Assessment section this device may be significant risk. You will be allowed to
submit the IRB application but final IRB approval will not be granted until the IDE number has been assigned or an
exempt or a NSR final determination is made by the IRB. If Yes to any question and you believe that the
investigation is NSR, provide additional justification to the IRB per the FDA guidance available at
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf
Section 5 Special Considerations for Investigator Initiated Research
Sponsor Investigators are required to complete the web-based Good Clinical Practice Course available
through the Collaborative Institutional Training Initiative (CITI). This course provides guidance on the
regulatory and institutional responsibilities of the sponsor-investigator role inmedical device studies.
This training must be successfully completed before IRB approval is granted.
5.1 Is this study conducted by a sponsor-investigator?
A Sponsor-investigator is an individual who both initiates and actually conducts, alone or with others, a clinical
investigation, i.e., under whose immediate direction the investigational device is administered, dispensed, or used.
The term does not, for example, include a corporation or agency. The obligations of a sponsor-investigator include
those of an investigator and those of a sponsor.
Yes
No. If no, Appendix F is complete.
5.2 Provide the date (Month/Year) the PI completed the required CITI course for sponsorinvestigators.
5.3 Has the PI transferred any sponsor obligations/responsibilities to the commercial sponsor, University of MN
or contract research organization, or other entity?
No.
Yes. Indicate roles and responsibilities transferred:
5.4 Check the boxes next to the statements below to confirm understanding and agreement:
The Principal Investigator confirms he/she is aware of the regulatory responsibilities as a sponsor-
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investigator
The Principal Investigator confirms he/she has reviewed and will comply with the University of Minnesota
Policy “Reporting Sponsor-Investigator IND/IDE and FDA Pre-Submissions”
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Appendix F – Use of Devices
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