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.
FDA 510(k) Submission Process
$49.00
- 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
Description
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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