Interesting Discussion FDA 510(k) required? US company Private Labeling an FDA Class II Device

H
#31
Hi, stumbled upon this useful website while researching rules and regulations for my business. Would anyone know what the rules are for the following:

I'm looking to import a 510k registered product under my own private label brand. However, the purchase will be made via a supplier (triangular or F2F shipping arrangement) who holds a CE mark and wants to be the 'manufacturer' on the box. My question is does the original manufacturer details need to be on the product box, per FDA rules? Do both the manufacturer and supplier need to be listed on the box? The product itself will be unchanged from the FDA registration description by the manufacturer so I don't think I need to have it registered. To be clear, the supplier itself is European and not registered with the FDA whilst the manufacturer is. I will be relieving the shipment straight from the manufacturer. Thanks in advance!

H
 
Elsmar Forum Sponsor
#32
There's quite a bit to unpack here. But some preliminary questions that may help the experts here provide you some good guidance.

1. What class is the device? EDIT: Class II - in the title!
2. Is your organization registered in the FURLS database?

Thread re: CE Marking and the USFDA - Is it Legal for Printing CE Mark in Label? FDA Aspect

Specific Labeling Issues you may encounter based upon your device - Device Labeling

It would be advisable to have your labeling reviewed by an expert prior to importing as there are a lot of little things that get you flagged and snagged.

With respect to using the European entity on the labeling. 21 CFR 801.1 states that you must include the manufacturer (who?), distributor (you) or packer (not relevant, seemingly) on the label. Europe employs the "legal manufacturer" concept and the legal manufacturer, if they don't actually physically manufacture the product, is not going to qualify as the manufacturer for USFDA purposes. The name on should be you or the actual manufacturer.

Hope this provides some useful starting points and information.
 
Last edited:
H
#33
There's quite a bit to unpack here. But some preliminary questions that may help the experts here provide you some good guidance.

1. What class is the device? EDIT: Class II - in the title!
2. Is your organization registered in the FURLS database?

Thread re: CE Marking and the USFDA - Is it Legal for Printing CE Mark in Label? FDA Aspect

Specific Labeling Issues you may encounter based upon your device - Device Labeling

It would be advisable to have your labeling reviewed by an expert prior to importing as there are a lot of little things that get you flagged and snagged.

With respect to using the European entity on the labeling. 21 CFR 801.1 states that you must include the manufacturer (who?), distributor (you) or packer (not relevant, seemingly) on the label. Europe employs the "legal manufacturer" concept and the legal manufacturer, if they don't actually physically manufacture the product, is not going to qualify as the manufacturer for USFDA purposes. The name on should be you or the actual manufacturer.

Hope this provides some useful starting points and information.
1) It is a class II medical device, so should be relevant to this thread.
2) Not yet registered in FURL, but will register shortly and before I place the order with my supplier. Just making sure I understand everything before I move forward with the order.

Will certainly have a professional look over the packaging (it is currently being drafted).

I thought that the European 'legal manufacturer' concept wouldn't work over here and you confirmed my suspicions. I will have to get this changed. Thank you for your comments. If you have any resources or comments, please share. This has been helpful!

H
 

Mark Meer

Trusted Information Resource
#34
...I'm looking to import a 510k registered product under my own private label brand. However, the purchase will be made via a supplier (triangular or F2F shipping arrangement) who holds a CE mark and wants to be the 'manufacturer' on the box. My question is does the original manufacturer details need to be on the product box, per FDA rules? Do both the manufacturer and supplier need to be listed on the box? The product itself will be unchanged from the FDA registration description by the manufacturer so I don't think I need to have it registered. To be clear, the supplier itself is European and not registered with the FDA whilst the manufacturer is. I will be relieving the shipment straight from the manufacturer. Thanks in advance!
Here is a helpful article. Admittedly it does not address your specific questions, but does present some relevant questions to ask to clearly establish roles/responsibilities beforehand.

I'm curious: you say that you will be "relieving the shipment straight from the manufacturer". So why go through the supplier middle-man? Would simplify things if you could just approach the manufacturer directly...
 
H
#35
Here is a helpful article. Admittedly it does not address your specific questions, but does present some relevant questions to ask to clearly establish roles/responsibilities beforehand.

I'm curious: you say that you will be "relieving the shipment straight from the manufacturer". So why go through the supplier middle-man? Would simplify things if you could just approach the manufacturer directly...
Thanks for the article. Yes, it would be easier to go direct to the source but the manufacturer has indicated it prefers going through the middle man and having a triangular arrangement because he does not want to upset existing relationships in certain markets. If the middleman doesn't agree to relabeling i will have no choice but to go direct with another supplier.
 
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