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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.


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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View frequently asked questions about IDE Development.
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