Regulatory Responsibilities of the Bureau of Medical Devices. Module V: Overview of the Medical Device Amendments. 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 V's Student Workbook. The Student Workbook provides historical information on events leading up to the passage of the Medical Device Amendments of 1976. The complete definition of a medical device and modifying terms are provided. Also included is a description of the classification process for medical devices, the device experience network, and the function of the Bureau of Medical Devices' Office of Small Manufacturers Assistance.