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Investigational Device Development

Investigational Device Exemption (IDE) Applications for Sponsor-Investigators

The IDE Development Process Overview

The sponsor of a Significant Risk (SR) device study is required to submit an IDE application to the FDA. The IDE allows the investigational device to be used in a clinical study in order to collect the safety and effectiveness data required to support a marketing application.

Toolkit

Step-by-Step Toolkit

View templates and guidance relevant to each step in the process. ITHS can review your application prior to submission.
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FAQ

FAQ

View frequently asked questions about IDE Development.
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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

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