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Device Form

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Device Form59.29 KB

Summary

If the project involves the investigation of any devices, mobile applications or algorithms, the study may be subject to the Food and Drug Administration (FDA) regulations.

Helpful Tips

  • Submit one form per device used in research.
  • Make sure any relevant FDA documentation is included with the device form. 

Full Details

About the Device Form

If the project involves the investigation of any devices, mobile applications or algorithms, the study may be subject to the Food and Drug Administration (FDA) regulations. Researchers planning to use devices in human subjects research must complete this form and include it with their protocol submission.  OPRS and the IRB will determine if FDA regulations are applicable to the study

When to Use This Form

If you answered yes to Section 12.1.9 (Studying the safety, effectiveness, or outcomes of any type of device, algorithm, or mobile application - medical or non-medical) in the New Study Application, you need to complete this form.

If you will be using devices in human subjects research for this study, and if you did not yet select yes in Section 12.1.9 of the New Study Application, please update the appropriate New Study Application section and then complete this form.

Type of Document

  • Forms