MSQ 571 - Regulatory Compliance for Medical Devices and Combination Products

Credits: (3)
This course examines U.S. medical-device development and approval requirements, including regulatory reforms implemented under the Food and Drug Modernization Act, Clinical Laboratory Improvement Amendments, the Center for Devices and Radiological Health reengineering initiatives, and evolving Investigational Device Exemptions; pre-market Approval; 510(k) application process; responsible product development, ethical protocol development and review processes. The course also explores emerging developments and trends in medical-device regulation in the United States. Topics include legal and ethical issues. [Online]