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Apr 27, 2024
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MEDDV 100 - Introduction to FDA Medical Device Regulation
1.0 Credits
Overview of FDA regulation and compliance for medical devices. Topics include U.S. Food and Drug law, medical device approval process, laboratory and clinical studies, introduction to Quality System Regulations (QSR’s), FDA inspection and enforcement processes.
Course Objectives
Upon successful completion of this course, students will be able to:
- Locate the Code of Federal Regulations (CFR) specific to the RDA regulations applying to medical device manufacturing. [REASON]
- Describe the classes of medical devices and determine the correct classifications for a variety of medical devices. [REASON]
- Explain and differentiate the 510K and Pre-market Authorization (PMA) approval processes. [COMMUNICATE]
- Outline the FDA inspection process including forms and enforcement actions. [REASON]
- Demonstrate an understanding of U.S. Food and Drug law. [COMMUNICATE]
- Describe the organization of the FDA and how it interacts with other federal and international regulatory agencies. [REASON]
- Explain and list the key elements of Quality Systems Regulation. [REASON]
- Define and describe Good Manufacturing Practices (GMP) and Good Laboratory Practices. [REASON]
- Explain why medical devices are regulated by the FDA. [EXPLORE]
- Explain the ramifications of non compliance. [ACT]
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