Course Content

2 Role of FDA; Safety & Effectiveness; Valid Scientific Evidence; Device Classification

Course Overview

1 Introduction

• 2 Safety & Effectiveness

Video
Slides
Quiz
Worksheet
References

3 Regulatory Pathways

4 Clinical Trials

5 Quality Systems

6 Intl Regulation

References

Glossary

Summary

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What you will learn in this section

• Mission & Role of FDA
• Statutory Basis for Regulation
• Definition of Safety and Effectiveness
• Definition of Valid Scientific Evidence
• Organization of FDA
• FDA Device Classification: Class I, II, III

Content

Play video

1. Jan Pietzsch on the role of the FDA
2. Howard Holstein on "Background of the FDA"

Slides (PDF) (Pietzsch talk)

Speakers' Biographies

Jan Pietzsch

Howard Holstein

Additional Materials

Assessment Quiz

Worksheet (pdf)

References (doc)

Determination of Safety and Effectiveness (doc)