Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 510(k)?

Many don’t understand it; the evidence is the large percentage of submissions that are rejected due to a lack of demonstrating substantial equivalence.

Today we’re talking with Mike Drues, President of Vascular Sciences about demonstrating substantial equivalence, so if you’re not rock-solid on the concept, you won’t want to miss this episode.


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Some of the highlights of the show include:

● Exactly what substantial equivalence means as it applies to the regulatory process and why it’s important.

● Why it’s challenging to demonstrate substantial equivalence.

● Mike’s approach to evaluating and demonstrating substantial equivalence.

● Some of the common errors that Mike sees in submissions that pertain to substantial equivalence.

● What happens if you get it wrong in the eyes of the FDA.

● An explanation of product codes and how they relate to substantial equivalence.

● Examples of how you might demonstrate substantial equivalence between common objects - stressing their similarities while de-emphasizing their differences.


Additional Links:

Evaluating Substantial Equivalence in Premarket Notifications

Mike Drues on LinkedIn

Vascular Sciences

Jon’s Ketchup and Mustard Video

Jon Speer on LinkedIn

Greenlight Guru


Quotes by Mike:

In all of my submissions... I try to tell a story... I want to make a readable document.

The data is the data, but we can present that data in many different ways.

I want to demonstrate at the end of the day that I know what I’m doing.



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