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

[Ronen E]

I feel that I might be having a blind spot - would appreciate a sanity check.

§807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to §807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:

(1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.

(2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section.

Item 2 seems to be saying that all new devices that are made by establishments requiring registration (e.g. Manufacturers) require a 510k submission, unless a PMA or a De-Novo is submitted for them (that's being said in paragraph (b)). Moreover, it seems that item 2 makes item 1 completely redundant. None of that makes sense to me.

 

[Watchcat]

And people wonder why I hate the 510(k).

 

[Marcelo]

I'm not sure if I understood you question, but you seem to imply that this requirement is related to registration (of establishments). But it's related to devices, not establishments. It only mentions establishments to link with the establishments registration requirements. In fact, all requirements under Subpart E--Premarket Notification Procedures are for device listing, and links to the previous parts on establishment registration.

But I do agree that, if you are not into the exact frame of mind, reading and understanding these can be difficult.

Also, please note that this text is from August 1977 (some months after I was born).

Anyway, the basic differences between 1 and 2 is that 1 applies to new devices, and 2 applies to devices which were already into commercial distribution before by a person (establishment) but are being introduced by another person (establishment).

Please note that the original text of the proposed regulations was:

(2) The device Is being introduced into commercial distribution or the first time by a person required to register, whether or not the device is the same type as and Is substantially equivalent to a device in commercial distribution. A person who reintroduces a device that was once in commercial distribution, but is subsequently discontinued, Is required to submit a premarket notification.

But the last part of removed in the final regulation because people complained that someone who already had a "cleared" device that was out of commercial distribution should not require a new premarket notification when reintroducing the device into commercial distribution.

 

[Ronen E]

I'm not sure if I understood you question, but you seem to imply that this requirement is related to registration (of establishments). But it's related to devices, not establishments. It only mentions establishments to link with the establishments registration requirements. In fact, all requirements under Subpart E--Premarket Notification Procedures are for device listing, and links to the previous parts on establishment registration.

No, that wasn't the issue. I'm clear about registration (establishments), listing (devices) and premarket notification submission (devices).

Also, please note that this text is from August 1977 (some months after I was born).

I didn't check this one in specific, but 21 CFR is amended from time to time through more recent legislation (similar to regulations in other jurisdictions). I didn't remember noticing and thinking about this issue before, so I thought maybe it was changed and somebody here knew something about it. I guess I'm being a little lazy... after all, it's the weekend
Added in edit: Turns out that this section was last amended in 2007. Not sure why it never bothered me earlier.

Anyway, the basic differences between 1 and 2 is that 1 applies to new devices, and 2 applies to devices which were already into commercial distribution before by a person (establishment) but are being introduced by another person (establishment).

The code says "a person required to register" (in item 2). That would include a company (manufacturer) opening a new facility on a different site (materially different address), because at that point the company (person) would be required to register (the new facility). Are you saying that that manufacturer would be required to submit another 510k, for a device they might have been making in the "old" facility? I guess you'd answer "No, because that person (company) already had the device in commercial distribution, so it's not being introduced for the first time by that person." Okay, so a tougher one: What happens when a company sells a product line, complete with the 510k, to another company starting a new facility (and thus required to register)? As far as I knew until now, there was no expectation of the buyer to submit their own 510k, i.e. it's perfectly okay to buy a 510k from someone and continue to rely on it even if the device is made on a different (even new) site. Are you saying this is not the case? I understand that if the equipment (and possibly the processes) is new it may be considered a significant change, which will require a new submission regardless of ownership transfer; but what if the product line was transferred as-is - same machines, same processes, same specifications, same work instructions etc.? I don't see a provision in item 2 to exempt from submission in that situation.

 

[Marcelo]

I didn't check this one in specific, but 21 CFR is amended from time to time through more recent legislation (similar to regulations in other jurisdictions). I didn't remember noticing and thinking about this issue before, so I thought maybe it was changed and somebody here knew something about it. I guess I'm being a little lazy... after all, it's the weekend
Added in edit: Turns out that this section was last amended in 2007. Not sure why it never bothered me earlier.

Some parts of the section yes, but the introduction and itens (1) and (2) are from the original 1977 rule.

The code says "a person required to register" (in item 2). That would include a company (manufacturer) opening a new facility on a different site (materially different address), because at that point the company (person) would be required to register (the new facility). Are you saying that that manufacturer would be required to submit another 510k, for a device they might have been making in the "old" facility? I guess you'd answer "No, because that person (company) already had the device in commercial distribution, so it's not being introduced for the first time by that person." Okay, so a tougher one: What happens when a company sells a product line, complete with the 510k, to another company starting a new facility (and thus required to register)? As far as I knew until now, there was no expectation of the buyer to submit their own 510k, i.e. it's perfectly okay to buy a 510k from someone and continue to rely on it even if the device is made on a different (even new) site. Are you saying this is not the case? I understand that if the equipment (and possibly the processes) is new it may be considered a significant change, which will require a new submission regardless of ownership transfer; but what if the product line was transferred as-is - same machines, same processes, same specifications, same work instructions etc.? I don't see a provision in item 2 to exempt from submission in that situation.

This case is dealt with by 807.85 (b) (2):

Sec. 807.85 Exemption from premarket notification.

(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:

(1) The device was in commercial distribution before May 28, 1976; or

(2) A premarket notification submission was filed by another person.

 

[Ronen E]

This case is dealt with by 807.85 (b) (2):

???
That section talks about distributors and repackagers. The scenario I described talks about manufacturers.

 

[Marcelo]

Oh, sorry, I made a little confusion on your questions and my answer.

The answer for the first question is that, if the manufacturer is legally authorized to market the existing device, he does not need to submit a new 510(k).

The second question is related to what is usually called a "transfer" of a 510(k). The FDA does not expect a submission of a new 510(k) and there's a transfer and the device is not significantly changed or modified, however, the FDA does require that the 510(k) transfer is "shown" in the next update of the (new) device establishment, when it is required to list their devices, including the 510(k) number (this would show the FDA that this establishment is the new 510(k) owner, but it's important to note that the previous "owner" cannot list the 510(k) when updating, because only one "owner" for one 510(k) can exist at a time.

 

[Marcelo]

Also, please note that in both cases, §807.81 a) (2) does not apply (as in both cases, the manufacturers ARE legally authorized to market the existing device).

 

[Ronen E]

The second question is related to what is usually called a "transfer" of a 510(k). The FDA does not expect a submission of a new 510(k) and there's a transfer and the device is not significantly changed or modified, however, the FDA does require that the 510(k) transfer is "shown" in the next update of the (new) device establishment, when it is required to list their devices, including the 510(k) number

This is what I thought as well, but this conclusion doesn't seem to follow from 807.81 in the scenario I described.

 

[Ronen E]

Also, please note that in both cases, §807.81 a) (2) does not apply (as in both cases, the manufacturers ARE legally authorized to market the existing device).

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.