How does a site know that a sponsor's medical device and study design will generate appropriate scientific evidence to justify or require a clinical trial? Sites may already be familiar with the sponsor and investigator responsibilities for Investigational Device Exemption (IDE) studies outlined in 21 CFR 812 of the Code of Federal Regulations, but this session will provide a tutorial on the regulatory expectations for IDE application submission or a non-significant risk (NSR) determination before initiating device clinical trials. The content will cover IDE applications and the documents that will be reviewed by the U.S. Food and Drug Administration before approving an IDE and how an NSR determination translates to abbreviated 21 CFR 812 requirements. Also discussed will be design controls to ensure a medical device is clinically ready for a clinical trial and how they still apply to NSR device studies including in vitro diagnostic products.

CEU: 1.00 ACRP

Speaker:

• Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA