FDA 510(k) Submission Process


This 510(k) Submission Video Course is designed to help you discover the 510(k) submission process and provide you with an overview on the submission review process, and applicable timelines.

  • Course Type: Video Lessons
  • Language: English
  • Level: Intermediate
  • Session: year 2021
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:00:45
Regulatory Information 00:06:47
Submission Preparation 00:05:21
Acceptance Review 00:04:50
AI Request and MDUFA 00:05:02
Conclusion 00:00:54

Exam and Certifications

  • Final Test – 510(k) Submission Process
  • Certification


What I will learn?

This course will highlight each and every aspect you need to learn regarding the 510(k) submission process, preparation of the submission, and components within the submission review procedure.

Skills I will gain

  • Understand what is a 510(k) submission
  • Explore the types of 510(k) submissions
  • Discover the preparation of the submission and submission review procedure
  • Learn who should submit a 510(k)
  • Understand when a 510(k) it would not be required


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