- 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)
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.
Why take this course
This Meditrial Video Course By Monique Latourette 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.
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
- Final Test – 510(k) Submission Process
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