In this video basics of the FDA 510(k) Premarket Notification are explained:
- Types of 510(k) Submissions
- Legally Marketed Device / Predicate Device
- Substantial Equivalence & Decision Making Flowchart
510(k) - Timeline & Costs
This video explains the following important requirements:
- How much will the 510(k) submission cost ?
- How long does a 510(k) take ?
- How do I plan my clearance time realistically ?