SeerPharma Pty Ltd :: DISCover web-based training :: MD-U 1: US Regulatory Affairs Overview

UK | Singapore

MD-U 1: US Regulatory Affairs Overview

Description: The medical device industry in the USA is governed by a number of important regulations. The most important of these are contained within the Code of Federal Regulations (CFRs) -- 21 CFR Part 800 series. This course introduces you to some of these regulations.

Price: $179 (AUD)

COURSE OUTLINE

INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and Assessment

OVERVIEW OF THE USA REGULATORY SYSTEM
4. USA Medical Device Industry
5. Medical Device Definition
6. The Food & Drug Administration (FDA)
7. Historical Perspective
8. Regulations
9. Review

CLASSIFICATION SYSTEM AND REGULATORY CONTROL
10. Medical Device Classification
11. Important Terminology
12. Example
13. Regulatory Control and Classification
14. General Controls
15. Special Controls
16. Premarket Approval
17. Classifications and Exemptions
18. Special Considerations
19. Review

CONCLUSION
20. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Define important medical device terminology
Locate the medical device regulations pertaining to particular areas of the industry
Describe the classification system of medical devices
Compare the characteristics of regulatory control required for each of the different classes of medical devices

SeerPharma is grateful for the endorsement of the DISCover Medical Devices series by:

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