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.
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.
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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