substantial_equivalence_fda_510k

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.

 

Listen Now:

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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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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.