UDI for US - Third Party device Repackager

#1
Hi:
My question is regarding the UDI for US. My company is a medical device manufacturer of software only product (already 510k cleared). In addition we also want to bring in US the third-party device + accessories (everything is 510K cleared). For that we are packaging everything together in a new package (sort of a briefcase) whie making no changes to the devices themselves or their original manufacturer's label..That is, we are just creating a new package that contains all the hardware components needed to acquire the signal that our software analyzes.
Question:
Given that I am not the owner of these other 510Ks:

1- Should I give a UDI# to this package and then I will enter all the information related to the other devices in the package in GUDID?
2- Should I just change my FDA registration to add repacking and then register a "new device"(package conformance) with all its components, under our name and then give UDI?
3- 1+2 above?

Would really appreciate any help here.

Thanks
Daniel
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
It seems that by so packaging you'll be making an implicit claim that this combination will work as intended, as a system.
Proceed to classify as a new product and act according to the results.
 
#4
It seems that by so packaging you'll be making an implicit claim that this combination will work as intended, as a system.
Proceed to classify as a new product and act according to the results.
In fact our 510k clearly states that the software works with all those components. Thanks for your response.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
In fact our 510k clearly states that the software works with all those components. Thanks for your response.
There may be a regulatory difference between simply making that statement (actually to CDRH and only indirectly to the public, if it's in the 510k summary) and supplying this specific combination of products packaged together. Thanks for your response too.
 
#7
There may be a regulatory difference between simply making that statement (actually to CDRH and only indirectly to the public, if it's in the 510k summary) and supplying this specific combination of products packaged together. Thanks for your response too.
What difference? what part of the regulations?

Also, the statement is included in the Summary. In addition, the manufacturer of the (hardware) device also includes the accessories on their 510K and they currently commercialize the device exactly as we will do...but within a different package.
My point is, that we are not making any new claim for the system....the device+accesories is already in commercial distribution by the manufacturer (510K holder) We are just changing the external package: Instead of a carton Box we use a briefcase.

My conflict here is between being the owner of the package UDI but not the owner of the package content 510K....

thanks
 

Watchcat

Trusted Information Resource
#8
doesn't seem to apply in my case
Sorry to hear that. I have a long-standing aversion to accessories, kits, systems, etc. Give me one nice. simple. standalone device, please. The rest make my brain hurt. Not that I won't deal with them, but, seriously, you have to pay me to do that. :) I won't even read the guidance otherwise.

The only thing I can add to this discussion is that, spring 2017, I attended a presentation by Jay Crowley (in charge of UDI at FDA) where he bemoaned all the different ways the industry combines, packages, repackages, labels and relabels. At the time, I asked if I were to give him a list of all the different scenarios I could think of, could he tell me how to handle them with respect to UDI. His answer was, without a moment's hesitation, an emphatic No. So don't feel bad if it's as clear as mud to you too.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#9
What difference? what part of the regulations?

Also, the statement is included in the Summary. In addition, the manufacturer of the (hardware) device also includes the accessories on their 510K and they currently commercialize the device exactly as we will do...but within a different package.
My point is, that we are not making any new claim for the system....the device+accesories is already in commercial distribution by the manufacturer (510K holder) We are just changing the external package: Instead of a carton Box we use a briefcase.

My conflict here is between being the owner of the package UDI but not the owner of the package content 510K....

thanks
The packaging, tradename, etc. are part of the 510k-cleared product. There is no regulatory provision that I know of to quickly clear "the same contents" in a different package and under a different tradename and manufacturer name. If you bought their pack, unpacked it and repackaged the contents you'd have been a repackager, but that's probably not what you plan. Right?

IMO your focus on UDI is distracting you. The real issue is putting a new product into commerce.
 
#10
The packaging, tradename, etc. are part of the 510k-cleared product. There is no regulatory provision that I know of to quickly clear "the same contents" in a different package and under a different tradename and manufacturer name. If you bought their pack, unpacked it and repackaged the contents you'd have been a repackager, but that's probably not what you plan. Right?

IMO your focus on UDI is distracting you. The real issue is putting a new product into commerce.
Thanks. Yes, yesterday I realized that UDI was not the main thing. Seems now the solution goes through a different venue, the repackager.

Thanks to help me clarify.
 
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