Managing the IDE (Investigational Device Exemption) Submission for Compliance Success

8 July 2014, Fremont, United States

Introduction

Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.