Convenience Kit Requirements

#1
Hello All,
My company makes convenience kits that include class I and class II devices. I am new to this role and finding that things may have been done incorrectly. I am having trouble finding the correct answers. I have read the guidance documents and still find myself with many questions.

for GUDID:
The kits are called kits, yet "KIT" is not checked off the class II device information is listed and the GMDN is for the class II device. Now that we will be moving to requiring the class I devices to be listed, how will this work? Should the kit have its own GMDN?

for Registration:
if so, should the kit be registered as a kit separately?
thank you for your assistance.
Regards,
~Auditgirl
 
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Watchcat

Trusted Information Resource
#2
I can't answer your question, and it may be too late anyway, but if you still need an answer, you will probably have better luck posting this in the forum on US device regulations, instead of this one, which is on FDA pharmaceutical standards.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
In my opinion it's not at all surprising that this query wasn't answered. It belongs in a category of queries that are likely to not be effectively answered at Elsmar. The characteristics of this category:
- The query involves multiple issues or a rather broad topic;
- The issues are too specific to have a lot of people already come across the exact (or very close) situation;
- The time and attention required for someone unrelated to come up with useful answers are significant; and
- The poster is unlikely to be both willing and able (no shortage of the former only) to offer any compensation, to justify the effort put into assisting (which is likely the reason that they posted at Elsmar in the first place).
 

Watchcat

Trusted Information Resource
#4
Ronen E, I share some of your perspectives in general, but in this case, I'm not sure if they all apply.

As an independent consultant, I have happily avoided involvement with UDI and GUDID, but I consider this to be a relatively narrow topic in and of itself, and, when you narrow it down to kits, even more narrow...although, as far as I can tell, the most onerous aspect of dealing with these regulations.

I think there are people in the industry who have dealt with this issue many times, and who could provide some useful input without having to research the issue. Whether these people participate in Elsmar, that part I don't know.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Ronen E, I share some of your perspectives in general, but in this case, I'm not sure if they all apply.

As an independent consultant, I have happily avoided involvement with UDI and GUDID, but I consider this to be a relatively narrow topic in and of itself, and, when you narrow it down to kits, even more narrow...although, as far as I can tell, the most onerous aspect of dealing with these regulations.

I think there are people in the industry who have dealt with this issue many times, and who could provide some useful input without having to research the issue. Whether these people participate in Elsmar, that part I don't know.
I don't disagree with your analysis, I just think it misses the main point (maybe my fault because I didn't make it explicit).

The issues in the OP may seem generic, and indeed their generic aspects are not that complicated. However, in my analysis providing effective answers (and I'm not talking here about good-old "chipping in" or "providing input", which I still respect) in this case and similar ones would require further interaction with the OP - exchange of specific information, probably not in the open forum because users, in my experience, normally don't want this kind of exposure. Even if we ignore for a moment the observation that most users abandon their queries at that point - I'm not sure why though I have some guesses - actually obtaining the necessary information and studying it to the degree necessary for providing responsible answers is too time-consuming for routine volunteering, even if the topic is not especially challenging. Of course, someone may make it their life mission or hobby to immerse themselves in this type of pro bono work, but this is not the case for me (I do it once in a while, when the cause seems worthy and circumstances allow it, but not routinely), and I don't know of any others here doing that. So - very easy to write a quick post saying something like "Generally speaking, in this kind of situation <5-minute worth of chipping in>; however, to responsibly answer your query I'll need much more info, please contact me if interested...", but what's the point?

Sure, there are a lot of knowledgeable people in the industry, but it seems most of them are not interested in volunteering for whatever reasons.
 

Watchcat

Trusted Information Resource
#6
I think I got your point, I'm just not sure that some generic advice won't be sufficient for her needs. But again, I haven't dealt with UDI/GUDID myself, so I can't say with certainty.

In any case, whether or not there is someone in the Cove that can and will answer her question, generically or specifically, is out of my hands. The only thing that I'm reasonably sure of is that, if there should be someone like this here, they would be unlikely to come across her question where it was originally posted.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
if there should be someone like this here, they would be unlikely to come across her question where it was originally posted.
Not quite sure.
I never browse by forums, I just go to "What's New", which shows all recent posts in chronological order.
Less likely, maybe. Unlikely? not really.

Either way, thanks for highlighting.
 

Watchcat

Trusted Information Resource
#8
I browse new posts when I have some extra time, but since my interest is in medical devices, most of them aren't relevant to me, so not quite needle and haystack, but not very efficient. I rely on alerts, which I have set up for all of the medical device forums. I'm inclined to think that most of the people who have deep knowledge of UDI/GUDID would also be interested in a limited number of forums.

In any case, the week has started, so now we'll see if anyone drops by who can give Auditgirl some useful generic guidance.

In the meantime, I was going to delete all my other posts, since they are just taking up space without addressing her question, but I can't delete them, so any other posters will just have to scroll, I guess.

IT SHOULD BE NOTED THAT THIS WAS AN OVERLOOKED QUERY FROM MID-SEPTEMBER, SO MAYBE NOT WORTH TAKING THE TIME TO RESPOND TO IT, UNLESS THE ORIGINAL POSTER SHOWS UP TO CONFIRM CONTINUED INTEREST IN THE MATTER.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#9
IT SHOULD BE NOTED THAT THIS WAS AN OVERLOOKED QUERY FROM MID-SEPTEMBER, SO MAYBE NOT WORTH TAKING THE TIME TO RESPOND TO IT, UNLESS THE ORIGINAL POSTER SHOWS UP TO CONFIRM CONTINUED INTEREST IN THE MATTER.
1. My point was that maybe it wasn't "overlooked" but rather doomed from the outset. Hopefully someone will prove me wrong here.

2. I think that if anyone is able and interested in answering it's still worthwhile, even if the OP has moved on. Someone else might be in the exact same situation in 5 months or 5 years.

PS
If anyone will answer on-point I will edit this thread so that the question and answer(s) will be concatenated without the intervening "why this is not being answered" discussion (I'll spin it off on it's own because I think it's worth something).
 
#10
I can't answer your question, and it may be too late anyway, but if you still need an answer, you will probably have better luck posting this in the forum on US device regulations, instead of this one, which is on FDA pharmaceutical standards.
Watchcat,
Your comment is confusing about this being posted in the wrong forum .... Where does it say pharma?
How do you decide where to post if the distinctions are not clear?
Just wondering...
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