This workshop provides information across the full range of medical device clinical trial activities. It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.

Learning Objectives

• Navigate the regulatory pathways for medical devices in the U.S.
• Explore practical aspects of investigator and monitor selection.
• Comply with the fundamentals of Good Clinical Practice (GCP).
• Explore practical aspects of conducting international clinical trials.

Workshop Outline

• Introduction to the Food and Drug Adminisration (FDA): history; law; definitions
• Medical device process and the three classes
• Clinical research process: types of clinical studies, clinical study controls, international studies, the guideline process
• Monitoring: five basic monitoring visits
• Adverse device experience: expected and unexpected
• Data management: data entry, data query, validation
• FDA bioresearch monitoring program: site audits