Q
QM Becky
Hi Everyone! I hope this post finds you all well!
I have a situation, I think I know the answer, but need some confirmation/opinions...who better to ask!
We have a number of 510(k)s that we own, but under which we are not currently or actively manufacturing and marketing products. These were part of an asset purchase of a company a few years ago, and our development team is now redesigning/resurrecting one of these product lines.
We know we will have to at a minimum submit a special 510(k) as there are some material changes that we are making to the product.
My question is really should we actually be submitting a new Traditional 510(k) all together. I think we should... but sometimes I'm overly conservative, so I need a gut check.
The very first question in the FDA's checklist for the submission of a Special 510(k) asks if it is being "submitted to modify a legally marketed device". Technically, I contend that no... it's not, because while we COULD legally market the device described in the 510(k), we are not, and have not for many years. I'm not even 100% sure that the company we acquired it from every actually did either. They purchased it in a sale a few years earlier and I don't believe they ever actual had them manufactured and marketed.
To further complicate matters, I don't have any of the predicate devices described in the original 510(k) - they've been discontinued - and I don't have any of our devices... because they've not been manufactured... meaning side-by-side testing is going to be a challenge. I do have some test results, but the older 510(k) is pretty vague and frankly, not very well put together.
So the question is.... special - with nearly all new data and full remediation of the original... or New/Traditional. I tend to lean toward new/traditional... but that extends the timeline for our project, which of course, no one wants me to do.
Really appreciate your thoughts on this one.
I have a situation, I think I know the answer, but need some confirmation/opinions...who better to ask!
We have a number of 510(k)s that we own, but under which we are not currently or actively manufacturing and marketing products. These were part of an asset purchase of a company a few years ago, and our development team is now redesigning/resurrecting one of these product lines.
We know we will have to at a minimum submit a special 510(k) as there are some material changes that we are making to the product.
My question is really should we actually be submitting a new Traditional 510(k) all together. I think we should... but sometimes I'm overly conservative, so I need a gut check.
The very first question in the FDA's checklist for the submission of a Special 510(k) asks if it is being "submitted to modify a legally marketed device". Technically, I contend that no... it's not, because while we COULD legally market the device described in the 510(k), we are not, and have not for many years. I'm not even 100% sure that the company we acquired it from every actually did either. They purchased it in a sale a few years earlier and I don't believe they ever actual had them manufactured and marketed.
To further complicate matters, I don't have any of the predicate devices described in the original 510(k) - they've been discontinued - and I don't have any of our devices... because they've not been manufactured... meaning side-by-side testing is going to be a challenge. I do have some test results, but the older 510(k) is pretty vague and frankly, not very well put together.
So the question is.... special - with nearly all new data and full remediation of the original... or New/Traditional. I tend to lean toward new/traditional... but that extends the timeline for our project, which of course, no one wants me to do.
Really appreciate your thoughts on this one.