Course Content

3 Regulatory Pathways; Premarket Notification (510(k)); Premarket Approval (PMA)

Course Overview

1 Introduction

2 Safety & Effectiveness

• 3 Regulatory Pathways

Video
Slides
Quiz
Worksheet
References

4 Clinical Trials

5 Quality Systems

6 Intl Regulation

References

Glossary

Summary

Provide FEEDBACK

• Review: Device Classification
• Three steps to obtaining Market Clearance from FDA
• What is a 510(k)
• What is a Pre Market Approval (PMA)
• Determination of Substantial Equivalence
• Investigational Device Exemption (IDE)
• Other Relevant Programs
• Clinical Trials Introduction
• Key Performance Indices from FDA

Content

Play video

1. Jan Pietzsch on Regulatory Pathways
2. Howard Holstein on Regulatory Strategy

Slides (PDF)

Speaker's Biographies

Jan Pietzsch

Howard Holstein

Additional Materials

Assessment Quiz

Worksheet (pdf)

References (doc)

FDA Regulatory Pathways and Eval Programs (pdf)

FDA ODE Programs Overview (pdf)

Cyberonics Case Study (pdf)