Investigational Device Development
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.
Learn More ›
Related Links
Contact Us
Contact Us
Request Services
Request Services
Please sign in below to access this form.
Access to this form is restricted to ITHS Members. Please sign in.
Not yet an ITHS member?
Members of ITHS are part of a unique catalyst that accelerates discoveries to practice. If you haven't signed up for an ITHS membership yet, learn more and join us.