Introduction

Human subjects research or educational activities involving the physical interaction of human beings, other than exclusively faculty or enrolled students, with manufactured devices (a) that have not been commercially obtained by the university or (b) that have been modified by university personnel or students for use are subject to the device safety review process as guided by UPP 2-3.

When is Device Safety Review required?

Device safety review is required if Marquette University personnel (faculty, staff, or students) are:

1. i. are manufacturing or fabricating a new device; or
ii. modifying a commercially available device

AND

2. i. transferring the device to non-Marquette personnel; or
ii. testing the device on non-Marquette personnel; or

Access the decision tree and definition of human subject and research for additional guidance.

I've determined that I need Device Safety Review. Now what?

1. NOTE: Approval is required prior to any testing or transferring of devices.
2. Complete the Manufactured and Fabricated Device Form and submit the original, along with any additional materials, such as Capstone Design Project Description, to:
• Ms. Melody Baker, on behalf of Dr. Jeanne Hossenlopp
  Holthusen Hall, room 305
  Milwaukee, WI 53233
  Phone: 414-288-1532
3. Upon review, the Vice Provost for Research may either (a) approve the device testing or transfer, or (b) determine that review/inspection by the Device Safety Advisory Board is necessary.
4. If review/inspection by the Device Safety Advisory Board is required, the Office of Research Compliance (ORC) will contact you to complete and submit the DSAB Review Form and supplemental materials to ORC.
5. Once the form has been received, a member of the Device Safety Advisory Board will review the form and materials and inspect/review the device in person.
6. After inspection/review, you may be required to make modifications to your device prior to final approval for testing/transfer.
7. If you plan to transfer your device to an individual external to MU, you may be required to complete the Release and Indemnity Form found in UPP 2-3.

Who do I contact if I have questions?

Contact Ben Kennedy, benjamin.kennedy@mu.edu, at (414) 288-1479 if you have questions.

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Mission Statement

The mission of the Office of Research Compliance, in cooperation with and in support of the Institutional Review Board, Institutional Animal Care and Use Committee, Radiation Safety Committee, and Institutional Biosafety Committee, is to facilitate safe and ethical research conducted by Marquette faculty, staff and students in the areas of human subjects, animal subjects, radiation safety and biosafety.