UW Research

Forms and Templates

WORKSHEET FDA Devices and the IDE Requirement


This worksheet provides information and support for individuals assessing whether an FDA-regulated study needs an IDE from the FDA before conducting the research.

Change Notes

Transfer content to TEMPLATE Worksheet; combine IDE worksheet and device risk worksheet into one; revise and reorganize content to clarify the process for determining when a researcher must obtain IDE approval from the FDA – 06.30.2022