510 (K) Pre-Sub meeting - Does it worth?

L

Lilla

Registered
#1
#1
We are about to submit our 510K, and we are considering to request a Pre submission meeting, but I heard it is a waste of time. If you have any experience on this issue, kindly share it with me.
 
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Y

yodon

Leader
Super Moderator
#2
#2
In my experience, it's always been extremely valuable. It doesn't guarantee a successful submission but at least you're on the same page with FDA going in. Most of my experience has been in somewhat unique cases. If the product is very much a "me too" and the path is crystal clear then maybe a presub may not be all that helpful.
 
L

Lilla

Registered
#3
#3
yodon said:
In my experience, it's always been extremely valuable. It doesn't guarantee a successful submission but at least you're on the same page with FDA going in. Most of my experience has been in somewhat unique cases. If the product is very much a "me too" and the path is crystal clear then maybe a presub may not be all that helpful.
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Thank you! How can I request this meeting?
 
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