Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme

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Program/Course ID: MDU3 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: 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		Objectives: 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.

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