Can anyone please explain this? (510k submission requirement)

Marcelo

Inactive Registered Visitor
#11
Sorry, I lost you.
807.81 doesn't refer to whether or not the manufacturer is authorized to market. It seems quite straightforward - it talks about when a manufacturer needs to submit a premarket notification. The only cases where where (a) doesn't apply (including (a)(2)) are those listed in (b), which don't help clarify the last scenario I described.

It seems like [cleared device} + [new ownership] + [new site] = new submission, even if nothing else has changed.
It does seem like that, but that's exactly what I meant before about the "frame of mind".

Although the regulation seems to say that the only cases where where (a) doesn't apply (including (a)(2)) are those listed in (b) as you mentioned, in fact the interpretation is a little more complicated.

The cases you mentioned would fall under 807.81 (a) (1). However, as the devices are being introduced into commercial distribution for the first time, a 510 (k) is not required.

So, formally, 807.81 (b) is not the only way to not require a pre market notification, 807.81 (b) is related only to PMA or De Novo.

Please note that the text of these sections were carefully written to prevent manufacturers from bypassing the automatic class III designation for new devices, and both situations you mentioned do not do that.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
The cases you mentioned would fall under 807.81 (a) (1).
The last words in the 1st paragraph of 807.81(a) are "...which meets any of the following criteria:"
This means that if a device/scenario that falls under even just one of the possibilities that follow [(1), (2) or (3)], the obligation conveyed in (a) applies. I fail to see why the last scenario I described doesn't fall under (a)(2), in which case the obligation to submit a 510k seems to apply since no exemption is provided anywhere (that I currently see) to relieve that specific obligation. I'm well aware that sometimes FDA chooses not to pursue obligations set forth by the regulations, but then they normally explicitly declare such "enforcement discretion" somewhere, which I didn't see anywhere in this context. Other than that, selectively ignoring obligations set forth by the regulations, based on some elusive "frame of mind" seems wrong and contradictory to proper regulatory transparency. If some requirement doesn't apply in a given scenario it should be reasonably easy to show why that is the case directly from the regulations, or at most with the assistance of official FDA guidance.
 

Marcelo

Inactive Registered Visitor
#13
The last words in the 1st paragraph of 807.81(a) are "...which meets any of the following criteria:"
This means that if a device/scenario that falls under even just one of the possibilities that follow [(1), (2) or (3)], the obligation conveyed in (a) applies. I fail to see why the last scenario I described doesn't fall under (a)(2), in which case the obligation to submit a 510k seems to apply since no exemption is provided anywhere (that I currently see) to relieve that specific obligation.
Unfortunately, even because you fail to see it, it does not mean that it's not there.

I'm well aware that sometimes FDA chooses not to pursue obligations set forth by the regulations, but then they normally explicitly declare such "enforcement discretion" somewhere, which I didn't see anywhere in this context.
Again, unfortunately, that's not the case. There's no "enforcement discretion" in this case.

Other than that, selectively ignoring obligations set forth by the regulations, based on some elusive "frame of mind" seems wrong and contradictory to proper regulatory transparency. If some requirement doesn't apply in a given scenario it should be reasonably easy to show why that is the case directly from the regulations, or at most with the assistance of official FDA guidance.
In fact, as I mentioned, it's easy to see directly from the regulation, but as I mentioned, you probably need the right frame of mind (and when I talking about "frame of mind"I'm talking about the frame of mind of the reader, not from the FDA, because for them the text has always been clear).

Besides from that, as I mentioned before, this text is 40 years old, and has not been changed, so implying that it's wrong or being treated wrongly does not seem like a good conclusion. What I usually think in these cases is, probably someone has been under these circumstances and had to get a solution, so usually the fact is that, although I myself cannot see the solution to the problem, the solution must exist somewhere (and I probably am not aware at the moment where it is).

In this particular discussion, due to the way that you created the thread, I was trying to answer in a way to show why the answer to your questions were in the regulation, but needed an interpretation. Also, as I did not know how much information you had, I was trying to avoid pointing some things specifically (I'm trying to be less "aggressive" in my statements, and particularly here in the Cove, I've been trying for some time to understand people before throwing a comment that might put people off), but in this particular case, there is guidance (even if you do not need a guidance to make the conclusion).

You can see some pointers the draft and preamble to the regulations, as I mentioned, and also in old 510(k) guidance (the ones from 1983 and 1990, for example). There's also a specific draft guidance for exactly the cases of transfer you mentioned: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers, which was published almost 5 years ago (but please note that guidances really are not created from scratch, they evolve from discussions over time, so these situations were not new even in 2014 when the draft was published).

If some requirement doesn't apply in a given scenario it should be reasonably easy to show why that is the case directly from the regulations
Finally, that's what I mentioned in my las post, both situations you mentioned clearly do not apply on the given scenario of 807.81 (a) (1), so there's no requirement for a premarket notification.
 

Ronen E

Problem Solver
Staff member
Moderator
#14
Unfortunately, even because you fail to see it, it does not mean that it's not there.
Please, by all means, enlighten me!... That's why I started this thread. But please also note that just saying "it's there" is not very convincing if you don't make a clear and specific argument to support that statement.

I'm glad we agree that this is not an instance of enforcement discretion. One less thing to look into.
In fact, as I mentioned, it's easy to see directly from the regulation, but as I mentioned, you probably need the right frame of mind (and when I talking about "frame of mind"I'm talking about the frame of mind of the reader, not from the FDA, because for them the text has always been clear).
How can it be "easy to see directly" if "the right frame of mind" is necessary?... What IS the right frame of mind? I always thought that the regulation should be (and is) accessible to people with uni-level English, average or better intelligence and several years of experience in successfully implementing these and similar regulations (all of which I consider myself to have).

I'm sure that this section is clear to the FDA. That's not the point. The point is understanding how the wording of the regulation leads to the FDA's practice (if need be, with the assistance of official FDA guidance or other FDA written explanations).
Besides from that, as I mentioned before, this text is 40 years old, and has not been changed, so implying that it's wrong or being treated wrongly does not seem like a good conclusion. What I usually think in these cases is, probably someone has been under these circumstances and had to get a solution, so usually the fact is that, although I myself cannot see the solution to the problem, the solution must exist somewhere (and I probably am not aware at the moment where it is).
I didn't intend to imply that the regulation is wrong or has been treated wrongly. I only wrote that to me it doesn't make sense at the moment, and I asked help in improving my own understanding. My conclusion was just as you described: "I myself cannot see the solution to the problem, the solution must exist somewhere." However, I don't usually suffice with someone saying to me "Rest assured, the solution is out there, somewhere!...", unless they point to where exactly it is and, preferably, also explain beyond doubt the connection, applicability, and rationale behind their argument. Of course, no one (including you) is obliged to meet that expectation, but unless they do I tend to stay sceptical. I hope you can excuse me for that. My motivation is to gain such a level of understanding that I am, in turn, able to explain it to someone else, beyond reasonable doubts I may encounter. I don't usually answer questions with "someone once told me that it's okay, though I'm not 100% sure why, so you should believe that too!" I want to be able to convince my audience with facts and solid arguments.
There's also a specific draft guidance for exactly the cases of transfer you mentioned: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers, which was published almost 5 years ago (but please note that guidances really are not created from scratch, they evolve from discussions over time, so these situations were not new even in 2014 when the draft was published).
Ah! Now this may be helpful. Thank you. I will have a look and come back if I find something interesting.

I didn't, at any point, intend to imply that this is something new, so the answer's age (any good answer) is not important IMO. I'm simply looking for a solid answer.
both situations you mentioned clearly do not apply on the given scenario of 807.81 (a) (1), so there's no requirement for a premarket notification.
807.81(a)(1) is irrelevant, because I was arguing that the last scenario I described falls under 807.81(a)(2). If that is the case (and at this stage you haven't explained why it's not; I'm actually not sure you are actually saying it's not, because you keep coming back to (a)(1)), then clause (a) [the paragraph before (1), (2) & (3)] applies, and it says that a premarket notification IS required. Item (2) would trigger it independent of item (1) ["any of the following"].
 

Marcelo

Inactive Registered Visitor
#15
How can it be "easy to see directly" if "the right frame of mind" is necessary?... What IS the right frame of mind? I always thought that the regulation should be (and is) accessible to people with uni-level English, average or better intelligence and several years of experience in successfully implementing these and similar regulations (all of which I consider myself to have).
Ok, when I mentioned "right frame of mind", I wanted to mean that mean that the reader would need, for example, to have read the things I mentioned before, such as the draft and preamble to the regulations and also old 510(k) guidance (the ones from 1983 and 1990).

For example, the guidances mention that: Captura de Tela 2019-10-30 às 02.53.25.png

The first bullet relate to 807.81(a)(1), the second bullet to 807.81(a)(2), and the third and fourth bullet, to 807.81(a)(3)
807.81(a)(1) is irrelevant, because I was arguing that the last scenario I described falls under 807.81(a)(2). If that is the case (and at this stage you ahven't explained why it's not; I'm actually not sure you are actually saying it's not, because you keep coming back to (a)(1)), then clause (a) [the paragraph before (1), (2) & (3)] applies, and it says that a premarket notification IS required. Item (2) would trigger it independent of item (1) ["any of the following"].
As clearly detailed in other documents, for example, the draft and preamble to the regulations and also old 510(k) guidance (the ones from 1983 and 1990), 807.81(a)(2) applies to the case where the device is marketed by another manufacturer than the original one. The problem here is, for the regulation, what you mention in the last scenario is not this case in 807.81(a)(2), because due to the "transfer", the "new" manufacturer is also considered the original one, even if it's was not. So (2) does not apply in this case, it would be (1), and because the device is not being introduced in the market for the first time, a notification is not required.
 
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