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