Pre-Submission after 510(K) Submission?

Dobby1979

Involved In Discussions
#1
Hi All.

It might have been Chinese whispers with interpretation being lost in transit but has anyone heard of the FDA asking you to go for a pre-sub AFTER you have submitted the 510(k)?

This sounds very weird to me, anyone else come across this?

Thanks.
 
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Dobby1979

Involved In Discussions
#3
It was not related to us, I heard through the whispers of someone else. I thought it was strange as I had not heard about this before.
 

Watchcat

Trusted Information Resource
#4
I would not take this a sign that the 510(k) made a good impression. :( See my comment about "too late" in the De novo discussion thread.
 

primavesvera

Involved In Discussions
#5
Are you sure it is not a Q-sub since pre-sub is one sort of it?
Our 510(k) is currently on hold and we have been given the opportunity to submit a Q-sub in order to resolve some issues.
So, it might be just that.
 
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