UW Research

Forms and Templates

WORKSHEET FDA Devices and the IDE Requirement

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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