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Establishment Registration and Device listing - Wording of 807.20 (a) (6)

#1
A US company has a 510(k), establishment registration as a manufacturer and specification developer, and a device listing for an 868.5260 breathing circuit bacterial filter. If this company wishes to outsource molding and assembly of this accessory device to a plastic molder in the US, is it necessary for the plastic molder to register and list? The plastic molder will provide the filter to the original company unlabeled, unpackaged, in bulk. The plastic molder does not sell or distribute to anyone other than the original company. The reason for my confusion is the wording of 807.20 (a) (6) which says "Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose...." If the product is not packaged and labeled for commercial distribution and the plastic molder is not performing commercial distribution, do they still need to register and list?
 
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#2
Can that filter be classified as a finished device!
1588042317608.png
If it does not fall under the definition of finished device, then the plastic molder doesn't need to register or list or pay. But if the filter is considered as a finished device, then the plastic molder will need to register/list/pay.
1588042386278.png

Two examples from my case:
  1. We have one suction device which employs a filter outsourced to a supplier. As our filter is just a component of our device and can not function on its own, it is not considered as a finished device as it has to be assembled with our suction device (finished device). So, in our case, the filter supplier does not need to register/list/pay.
  2. For the same suction device, we have a fluid collection container from another supplier. The container is considered as a finished device as it can function on its own although it was not packaged, labeled or sterilized by the supplier and we do everything for it. The supplier still needs to register/list/pay.
To my understanding, it does not matter if your plastic molder commercially distributes the same product or any other product (to other than your company) in the US. If they are manufacturing a finished device, for transparency, they will need to register/list/pay and maintain the registration every year. They should also be ready for any sudden inspection by the FDA.

I hope this will help you to clear your doubts.
 
Last edited:

Ajit Basrur

Staff member
Admin
#3
A US company has a 510(k), establishment registration as a manufacturer and specification developer, and a device listing for an 868.5260 breathing circuit bacterial filter. If this company wishes to outsource molding and assembly of this accessory device to a plastic molder in the US, is it necessary for the plastic molder to register and list? The plastic molder will provide the filter to the original company unlabeled, unpackaged, in bulk. The plastic molder does not sell or distribute to anyone other than the original company. The reason for my confusion is the wording of 807.20 (a) (6) which says "Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose...." If the product is not packaged and labeled for commercial distribution and the plastic molder is not performing commercial distribution, do they still need to register and list?
If the outsourced plastic molder manufactures an "accessory" and although they do not perform commercial distribution, they may be required to register as "Contract Manufacturer".
 
#4
As long as the Plastic Molder is not putting the finished device into commercial distribution AND is not selling it's components as packaged/labeled accessory or components (i.e. contract manufacturing) to the original company, they do not need to register and list.
If this company wishes to outsource molding and assembly of this accessory device to a plastic molder in the US
Does this mean that Plastic Molder is also a kit assembler? To me, outsourcing the assembly of the device means something like somebody else putting together the components for you.
It doesn't seem like it but better to clarify :)

Hope this helps,
Heena
 
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