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.
This website will help faculty navigate the process of developing a Sponsor-Investigator IDE. For a more comprehensive introduction to device development, please refer to FDA’s Device Advice section. CDRH has also published new case studies which are useful tool in learning the regulation of medical devices.
The information provided in the following links pertains to Class III devices, that is, devices with the greatest risk or those that have a new intended use or employ a new, unique technology. For additional information or assistance with your program, please contact VCTRS directly (email@example.com)
At left is a step-by-step toolkit. Click on the links for templates and guidance relevant to each step. VCTRS can help draft and review your submissions as well as determine a communication plan with the Agency.