Change to the FDA cleared device (ours) - Submission or Letter to file?

Timothea

Involved In Discussions
#1
Hello, fellow Elsmar members!
I don't know how to solve my problem, so I thought maybe another pair of eyes would help me.
Basically, my company has made a change to the FDA cleared device (ours) and we wanted to submit a Special 510(k). However, my colleagues are suggesting to letter to file instead of submission. We finally came to an agreement - send a Q-sub to the FDA to check with them what to do.
Still, something feels off to me. Is there any other way to check with the FDA if it is necessary to send a Special or just Letter to File?
Thanks in advance.
Cheers!
 

Timothea

Involved In Discussions
#3
Yodon,
Yes, I've looked at it before, but it does not solve the problem. Maybe I wasn't clear enough. What I wanted to know is if there is any other way to contact FDA to get their feedback on this matter? Other than Q-Sub.
The thing is that we wouldn't want to get into trouble by not informing FDA.
I don't know if any of this makes sense, if it were only up to me, I'd do it as a Special.
Thanks.
Cheers.
 

yodon

Staff member
Super Moderator
#4
Not that I know of.

My experience has been that if you follow the guidance and document your conclusions (with proper rationale, etc.), you won't get sideways with the FDA. They may disagree in the end but if you do your due diligence (with good documentation), it can be worked out.

I've never come across a case where, after following the guidance, the answer hasn't been fairly clear. I realize there could be situations that fall in the gray. In those cases, it would seem most prudent to be conservative and file a special.

A regulatory expert (which I am NOT) can be gold here.
 

katiesam

Starting to get Involved
#5
I have had success emailing the lead reviewer that dealt with the original 510(K). However our device was only cleared last year so that may not be helpful if it wasn't a recent clearance.
 

Timothea

Involved In Discussions
#6
I have had success emailing the lead reviewer that dealt with the original 510(K). However our device was only cleared last year so that may not be helpful if it wasn't a recent clearance.
Katiesam, that is actually pretty good advice, our last device got cleared last year as well. I didn't know that it was possible to email lead reviewers like this. Thanks!
 

Timothea

Involved In Discussions
#7
Not that I know of.

My experience has been that if you follow the guidance and document your conclusions (with proper rationale, etc.), you won't get sideways with the FDA. They may disagree in the end but if you do your due diligence (with good documentation), it can be worked out.

I've never come across a case where, after following the guidance, the answer hasn't been fairly clear. I realize there could be situations that fall in the gray. In those cases, it would seem most prudent to be conservative and file a special.

A regulatory expert (which I am NOT) can be gold here.
Yodon,
Thanks for all the answers, I'm thinking in the same way as you.
 

katiesam

Starting to get Involved
#8
Katiesam, that is actually pretty good advice, our last device got cleared last year as well. I didn't know that it was possible to email lead reviewers like this. Thanks!
Neither did I, but I gave it a go thinking that I had nothing to loose. He took a week to respond, but he said they were looking into it to make sure they gave us the best advice. I went through the guidance with a fine tooth comb (as one has to do to work out which route to take in most circumstances) and was still left in a 'grey' area.
I don't want the hassle of having to justify myself during an inspection, so figured if I asked the FDA directly for advice then at least I could say that I had followed their lead.
Good luck, I hope you get the answers soon. I am still waiting, I'll update if I do hear.

My other line of thinking was that it is better to apply for a special 510(k) and be told you can put a letter to file; than the other way round.
 

Timothea

Involved In Discussions
#9
Neither did I, but I gave it a go thinking that I had nothing to loose. He took a week to respond, but he said they were looking into it to make sure they gave us the best advice. I went through the guidance with a fine tooth comb (as one has to do to work out which route to take in most circumstances) and was still left in a 'grey' area.
I don't want the hassle of having to justify myself during an inspection, so figured if I asked the FDA directly for advice then at least I could say that I had followed their lead.
Good luck, I hope you get the answers soon. I am still waiting, I'll update if I do hear.

My other line of thinking was that it is better to apply for a special 510(k) and be told you can put a letter to file; than the other way round.
Katiesam, thanks, our way of thinking doesn't diverge much. :)
 


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