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Episode 57  |  34:21 min

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important

Episode 57  |  34:21 min  |  11.07.2019

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important

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This is a podcast episode titled, What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important. The summary for this episode is: 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.
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.

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