Special 510(k) or New Traditional - Currently Inactive Products

QM Becky

Involved In Discussions
#1
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.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
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.
All this is quite irrelevant. In FDA's terminology "legally marketed device" equals "has a cleared 510k or PMA", regardless of actual marketing in the everyday meaning.

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.
If you submit a Special, your predicate will be "your" original device and not the predicate of the original 510k, so the older predicate will be mostly irrelevant. Second, for a special 510(k) submission you don't necessarily need side-by-side testing. Since both predicate and new version are yours (sort of :)), a theoretical comparison, including sufficient technical details, might be enough. Focus on the changes, you don't need to "prove" that the rest has stayed the same - that's the default premise in a Special. If you have the original specifications for the features / functions that are changing (eg drawings, BOMs), that should do.

Besides, if you go for a Traditional you will still have all the same issues with the predicate / establishing a baseline.

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.
I'd go for a Special, no matter how "thick" the file will be. It should be more streamlined.

BTW, there's no requirement to "fix" all the old submission's shortfalls while you're at it. Just make sure that the new submission is up to mark.

Good luck,
Ronen.
 

mihzago

Trusted Information Resource
#3
I agree with Ronen.
I will add a few more thoughts.
You may have to file a Traditional if you change the indications for use (e.g. expand patient population), and/or require clinical data to demonstrate safety and effectiveness. From your description it seems you're just changing the material so Special should work.

You will also have to describe an changes made to the device since the last 510(k); there may have been some changes before your company acquired the assets, but that does not change the submission type.
 
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