US FDA Investigational Device Exemption (IDE) Overview
According to the risk factor surrounding any investigational device, an investigational device exemption (IDE) is required by the FDA in order to allow the investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data in support of a PMA application and in some cases, a 510(k) submission.
Sounds simple enough – let’s do it. So where do we start?
This 4 part course by US regulatory expert Carole Stamp outlines FDA regulations related to US clinical studies for medical devices and will provide you with a comprehensible and clear look at the IDE application process, differentiating significant and non-significant risk studies, addressing typical problems that can arise during studies as well as an overview of FDA inspection procedures and requirements.
Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend FDA regulations related to US clinical studies for medical devices and the IDE process.
- Recognize the differences and implications involved with significant and non-significant risk studies.
- Identify and address typical problems during clinical studies that can have a direct affect an IDE.
- Define FDA inspection procedures and requirements relevant to IDE approval.
Any professional who is part of an IDE study team.