Pre-Submission after 510(K) Submission?

Dobby1979

Involved In Discussions
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.
 

Dobby1979

Involved In Discussions
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
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
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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