Biography
Biography: Kate Simon
Abstract
This presentation by a former FDA reviewer will provide an overview of FDA regulation of in vitro diagnostic devices (IVDs). This presentation will help audience members make the leap from discovering a new biomarker to marketing an FDA approved or cleared diagnostic test. Design of appropriate analytical and clinical validation studies to support subsequent IVD data submissions to FDA will be covered, as well as best practices for preparing an FDA premarket submission. Seasoned professionals as well as those new to in vitro diagnostics will benefit from hearing about IVD device regulation from a former FDA reviewer. This will better enable them to prepare for IVD device clinical trials and subsequent data submission to FDA.