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
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