FDA 510(k) Overview

Get to know this common FDA clearance path and understand when you'll need to use it.

Curriculum0 hr 34 min

Introduction 0 hr 2 min
What is 510(k)?
Why 510(k)? 0 hr 1 min
510(k) and the other FDA Pathways 0 hr 3 min
Classification and Substantial Equivalence 0 hr 2 min
Determining Equivalence 0 hr 2 min
What has to be included?
Required Sections for a 510(k) submission 0 hr 3 min
A Few Pointers 0 hr 6 min
Other Tips and Tricks
510(k) Types 0 hr 4 min
Most Common Rejection Reasons 0 hr 3 min
Understanding the FDA Review Process 0 hr 5 min
Summary
Wrapping things up... 0 hr 2 min
Conclusion 0 hr 1 min

Curriculum0 hr 34 min

Introduction 0 hr 2 min
What is 510(k)?
Why 510(k)? 0 hr 1 min
510(k) and the other FDA Pathways 0 hr 3 min
Classification and Substantial Equivalence 0 hr 2 min
Determining Equivalence 0 hr 2 min
What has to be included?
Required Sections for a 510(k) submission 0 hr 3 min
A Few Pointers 0 hr 6 min
Other Tips and Tricks
510(k) Types 0 hr 4 min
Most Common Rejection Reasons 0 hr 3 min
Understanding the FDA Review Process 0 hr 5 min
Summary
Wrapping things up... 0 hr 2 min
Conclusion 0 hr 1 min