Regulatory Responsibilities of the Bureau of Medical Devices. Module VIII: Premarket Approval and Product Development Protocols. Leader Guide and Student Workbook

摘要

This leader guide contains the following five components: (1) Leader Introduction, (2) Session Plan, (3) Student Workbook, (4) Pretest and Post-Test, and (5) Videotape Script. The Leader Introduction covers general planning and teaching techniques for a small or large group setting. The Session Plan provides the instructor with specific information on planning and leading a training session covering the information contained in Module VIII's Student Workbook. After initial classification, a medical device must undergo a process of scientific review to ensure the safety and effectiveness before being marketed. This Student Workbook deals primarily with Premarket Approval, the Application contents, review process, as well as an explanation of the time requirements for manufacturers. Highlighted material includes the Product Development Protocol and its evaluation process.