Regulatory Responsibilities of the Bureau of Medical Devices. Module III: The Regulation of Biologics and Radiation-Emitting Products. 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 III's Student Workbook. The Student Workbook contains two parts. In Part I, the Radiation Control for Health and Safety Act is highlighted. This unit provides specific information on performance standards, mandatory recalls, and recordkeeping requirements. In addition, the Act's relationship to the Medical Device Amendments is summarized and an appendix on independent and shared responsibilities for FDA's Bureau of Radiological Health and the Bureau of Medical Devices is included. Part 2 includes historical information on the Biologics Act, the definition of a biologic, and licensng requirements. Also mentioned is the regulation of biologics under the Food, Drug, and Cosmetic Act.