FDA regulatory considerations for clinical trials conducted in the US, including First in Human and Early Feasibility Studies

More and more US FDA pre-market submissions are requiring clinical data for clearance and approval.  Understanding the regulatory landscape for clinical trials conducted in the US is an important aspect to ensure appropriate regulatory requirements are met, your data will support a subsequent pre-market submission, and reduce regulatory hurdles.  In this presentation, you will learn the difference between non-significant risk and significant risk device studies and how it affects your regulatory requirements. 

You will also learn about Investigational Device Exemption (IDE) submissions, when they are required, when to submit, required elements of an IDE submission, and avoiding common mistakes.  FDA’s review process for IDEs, including timelines, final decisions, and categorization for reimbursement will also be discussed as well as other aspects related to IDEs, such as FDA reporting requirements and how to address device or protocol changes.  You will also learn about the role of pre-submissions in obtaining FDA feedback on your planned clinical trial protocol as well as special considerations for First in Human and Early Feasibility studies.

Presented by: Dr. Kristy Katzenmeyer-Pleuss, Ph.D. | Senior Medical Research Manager, Regulatory | NAMSA GmbH