Regulatory Responsibilities of the Bureau of Medical Devices. Module VI: Classification. Leader Guide and Student Workbook

摘要

The 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 VI's Student Workbook. The Student Workbook covers the classification system in the Bureau of Medical Devices. Classification provides the FDA with a means for matching levels of regulatory controls to individual or generic classes of devices. Specific information on the requirements of the three classes into which medical devices are categorized--General Controls (Class I), Performance Standards (Class II), and Premarket Approval (Class III)--is provided. The composition of the classification panels, their activities, and the classification review process is also covered. In addition, this module describes the mechanism for changing a product's classification.