Description
This module will introduce you to the activities that are required before a device is ready to go to market in the US. The MDU-1 US Regulatory Affairs Overview module is a useful introduction to this module.
Course Objectives
Students completing this course should be able to:
- Describe the purpose of the Premarket Notification 510(k) Program
- Determine when a 510(k) submission is required and when it is not required
- List the three types of 510(k) submissions and give examples of when each is required
- List the essential elements of a 510(k) submission
- List the additional requirements and give examples of when they are required
- Describe the 510(k) submission process
Course Outline
INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and assessments
OVERVIEW OF REGULATORY REQUIREMENTS
4. Introduction
5. Medical device exemptions
6. Substantial equivalence
7. Regulatory requirements
8. Who needs to submit a 510(k)
9. When to submit a 510(k)
10. When a 510(k) is not required
11. Preamendment devices
12. Topic review
TYPES OF 510(k)
13. Introduction
14. The new 510(k) paradigm
15. Content of the 510(k)
16. Content of the Traditional 510(k)
17. Content of the Special 510(k)
18. Abbreviated 510(k)
19. Content of the Abbreviated 510(k)
20. Topic review
ADDITIONAL 510(k) REQUIREMENTS
21. Introduction
22. Sterilization and shelf life
23. Biocompatibility
24. Software
25. Electromagnetic compatibility
26. Performance testing
27. Topic review
SUPPORTING 510(k) DOCUMENTATION
28. Introduction
29. 510(k) cover letter
30. Cover letter design factors
31. 510(k) Summary or Statement
32. Truthful and Accurate Statement
33. Topic review
510(k) SUBMISSION PROCESS
34. Introduction
35. Acceptance and review
36. Requests for additional information
37. Decision letter
CONCLUSION
38. Summary I
39. Summary II