Medical Device not on commercial distribution but installed in the establishment. 510k?

PacoRabanez

Starting to get Involved
#1
Good morning all.

I am a little bit confused on what to do about submitting or not a 510(k) of a medical device (with its product code).
It is already installed and used in an italian establishment. The intent is to install it and use it only in the US establishment and not to sell it.
Its product code states that a 510(k) is required.

Reading the 21 CFR about 510(k):
Sec. 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.


But, from the definitions of commercial distribution in the 21 CFR 807.3 it is stated:
(b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following:
(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;


So, since what above, should we need to submit a 510(k) even if we are not going to sell the device into US market, but only use it in our US establishment?

I hope to read you soon.
Greeting to all.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
In my opinion yes, you'd need to submit a 510k (unless you clear it through a different route, e.g. IDE):
1. It was clarified somewhere (I can't remember where at the moment) that "commercial distribution" includes cases where no payment, or an actual sale, is made (e.g. "gifting", loaning etc.).
2. The exception you quoted about transfer between establishments is related to Manufacturers.

In effect, you will be introducing an otherwise uncleared device to use for the first time within the USA.

Caveat: This is STRICTLY my own analysis and opinion. I don't represent any authority or consensus.
 

PacoRabanez

Starting to get Involved
#3
In my opinion yes, you'd need to submit a 510k (unless you clear it through a different route, e.g. IDE):
1. It was clarified somewhere (I can't remember where at the moment) that "commercial distribution" includes cases where no payment, or an actual sale, is made (e.g. "gifting", loaning etc.).
2. The exception you quoted about transfer between establishments is related to Manufacturers.

In effect, you will be introducing an otherwise uncleared device to use for the first time within the USA.

Caveat: This is STRICTLY my own analysis and opinion. I don't represent any authority or consensus.
Thank you very much for the response.
1. It would be nice know more about "commercial distribution" and its definition. In that case, it would be clear that a 510(k) is required.
2. The italian establishment is also the manufacturer of the software. That's why I focused on that exception. They would install the system also in their USA plant.

In my opinion, and reading over the regulation material, a 510(k) is required, untill I read that exception. That is getting me a lot confused.

3. Can the software system be considered as "equipment"? In that case are there specific regulatory requirements to satisfy besides the validation?
 

Watchcat

Trusted Information Resource
#4
I think "commercial" is likely to be interpreted more broadly here, If the company is installing it in the US, it seems a virtual guarantee that the company thinks that doing so will serve its commercial interests, directly or indirectly.

At a regulatory conference I attended long ago, someone in the audience described a situation in which they thought FDA had exceeded its statutory authority. A device attorney answered. "Yes, you are right. And if you have a whole bunch of lawyers sitting around with nothing better to do..." [He never finished the sentence because at that point the entire audience burst out laughing.]

This is not something I would do without consulting a US medical device attorney.
 

PacoRabanez

Starting to get Involved
#5
I think "commercial" is likely to be interpreted more broadly here, If the company is installing it in the US, it seems a virtual guarantee that the company thinks that doing so will serve its commercial interests, directly or indirectly.

At a regulatory conference I attended long ago, someone in the audience described a situation in which they thought FDA had exceeded its statutory authority. A device attorney answered. "Yes, you are right. And if you have a whole bunch of lawyers sitting around with nothing better to do..." [He never finished the sentence because at that point the entire audience burst out laughing.]

This is not something I would do without consulting a US medical device attorney.
Many thanks to you too for the reply.
I e-mailed to the CDRH and to the CBER (since the establishment is under its "regulatory field") but they did not answered yet.
I hoped it could have been an already discussed topic.

In case of 510(k), does the establishment register in FURLS database, even if it is already registered under CBER establishment database?

Maybe someone personally faced the situation and will give an answer or his/her opinion.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
@PacoRabanez: I'm starting to get confused. It's unclear to me what exact sort of establishment/facility/plant (?) the one in Italy is, and the same for the one in the USA (initially I thought of some HC facility but I'm not sure anymore). I feel that it matters.

Is the device of interest a stand-alone software that is also a medical device (SaMD)? That matters too. To answer your question, yes, SaMD also falls under "equipment" in this context.

If indeed the object of interest is a medical device that requires a 510k and your org is its manufacturer, I believe that establishment registration through FURLS will be required regardless of other registrations. But that's a general statement and the details need looking into carefully.

You might want to contact DICE rather than CDRH (or CBER) directly - they are (at least in theory) more industry-support oriented.
 

PacoRabanez

Starting to get Involved
#7
I'm sorry and thank you for the considerations.
The italian establishment produces and manages blood components for further manufacturing operations.
The same is for the USA one.

It should be a SaMD because it should be indipendent from the device or the hardware in general. In which sense could it matter?

I mailed to CBER but waiting response about the registration.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I give up - with every post it becomes more ambiguous, and I've depleted my volunteering patience. I also feel it's slipping out of my field (I'm not experienced with blood products). Sorry.

Perhaps someone else will do a better job than me. Or hopefully CBER will help - I have zero experience with them and know them only theoretically.
 

PacoRabanez

Starting to get Involved
#9
Thank you very much for the patience.
I know it is not a standard case since they told me they don't want to sell it but only using to track internally in their US establishment.

I hope CDRH or CBER will clarify some aspects.
If anyone has some suggestion, you're welcome.
 
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