The Investigational Device Exemption: When is it Needed and How is it Obtained Most Easily - Webinar By GlobalCompliancePanel

28 September 2011, de, United States

Introduction

We will discuss the situation of the "sponsor/investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that which it is intended will also be considered. The concept of "non significant risk” is important in this context.