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Analysis of 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; product development protocol development and review processes. The course also explores emerging developments and trends in medical-device regulation in the United States. Prerequisite: QARS 401 or CLIN_RES 400 or consent of instructor. This class may be taken as an elective for MCRRA.
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Days: TBA |
Time: TBA |
Sec. 50 |
Cancelled
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Dates: TBA
Instructor:
TBA
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