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