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