B04 - When Is an Investigational Device Exemption (IDE) Needed for Medical Device Clinical Investigations?
Wednesday, November 17, 2021
1:45 PM – 2:45 PM ET
Location: Livestreamed
In general, the IDE regulations apply to clinical investigations of medical devices designed to determine safety and effectiveness. The IDE regulations at 21 CFR 812 describe three types of device studies: significant risk, nonsignificant risk, and exempt studies. So, which studies require the submission of an IDE application, and who determines which studies require an IDE? What is the applicability of the IDE regulations when the product is a companion diagnostic or when the clinical evidence is being generated in the real world?
Learning Objectives:
Provide an overview of the applicability of the IDE regulations that address when an IDE is required for Medical devices
Discuss how to apply the IDE regulations to studies involving investigational and marketed medical device products, particularly when data may be gathered in the real world
Review considerations to assist sponsors and IRBs in understanding when an IDE might be needed for a clinical investigation of a companion diagnostic and considerations for real world clinical evidence generation
