I'm going to call on a few friends to get you answers, Danny. First one that comes to mind is @Gary Saner, my go-to for UDI questions.

Hi Danny,

The FDA is unique in that they allow either the distributor or the manufacturer to be identified on the label, but both are not required. Therefore, if Joe Hage were the distributor and you were the manufacturer there are two legal options for the private label:
1) Distributed by Joe Hage
2) Manufactured for Joe Hage

The manufacturer is not required to be identified on the label. However, the OEM must be registered and listed with the FDA and if the OEM is outside the USA, then the distributor must register and list with the FDA as the initial importer and reference the K number when they complete the listing. There is no approval required by the FDA. You will need a legal agreement defining roles and responsibilities of each party, but that is all.

Regarding the UDI...the labeler is the one that is responsible for the GUDID--even if the name on the label is the private label company. If the product is shipped in bulk to the USA, and then labeled by the private labeler, then the private labeler is responsible for registering as the repackager and relabeler of the product and they must maintain the GUDID.

Classic Packard. 🤯

Thanks, Rob. Detailed, informative, actionable.

Rob, thank you so much!

Hi Danny,
It appears the OEM medical device is imported into the U.S. and then relabeled with the private labeler’s name. As mentioned above, the private labeler is considered a “relabeler” by the FDA and as such, becomes the UDI “Labeler” company responsible for placing UDI on the product and for reporting UDI data to the FDA Global UDI Database (GUDID). A new UDI representing the private labeler would need to be used. The product cannot have two UDIs, so make sure the OEM UDI is removed.
Gary gsaner@reedtech.com

Hi Gary,
Thanks for the response.
The OEM is based in the US.

Danny

Danny,
Just to clarify, the FDA UDI requirements apply to relabelers if the OEM is U.S. based or foreign. Gary gsaner@reedtech.com

Hi,

what is the difference between a relabeler and a private labeler, respectively what am I allowed to change as a private labeler w/o becoming a relabeler?
Our daugther comany in the US gets an medical device from another company in the US, which manufactures and markets the medical device under its own brand. We have changed the logo and company name on the label, the article number and Distributed for address of our company. Are we still a private labeler?
If no, what are we allowed to change on the logo?

Thanks
Simone
(simone.peschl@sutter-med.de)

Simone – The business relationship with your supplier and activities performed at your establishment influence the FDA type of your establishment. Various scenarios exist.

Example 1: Alpha Company manufactures a device under contract for two Private Labelers, Beta Company and Gamma Company; they commercially market “their” product under the Beta and Gamma brands respectively (it does not matter who physically applies the labels). Alpha is the “Contract Mfr,” Beta is the “Mfr” and “UDI Labeler” of the Beta product, and Gamma is the “Mfr” and “UDI Labeler” of the Gamma product.

Example 2: Alpha Company manufactures, commercially markets, and sells a device to Beta Company who distributes the product (no changes to the label, although “Distributed by Beta” is allowed to be added to the OEM label). Alpha is the “Mfr” and “UDI Labeler” and Beta is the “Distributor.”

Example 3: Alpha Company manufactures, commercially markets, and sells a device to Beta Company who replaces the Alpha OEM label with a Beta label and commercially markets the “Beta” product. Alpha is the “Mfr” and “UDI Labeler” of the Alpha OEM product and Beta is the “Relabeler” and “UDI Labeler” of the Beta product.

Per the FDA, a relabeler establishment: “Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.”

Gary gsaner@reedtech.com

Hi Gary,

thanks a lot for your answer and the examples, showing very clearly what actions change the status of the contributing companies. The definition of the FDA "that do not change the original labeling but merely add their own name" leaves some leeway what is really allowed to be added.

Simone

Simone

Gary,

I have a question about your example 2 above where Alpha Company manufactures, commercially markets, and sells a device to Beta Company who distributes the product (no changes to the label, although “Distributed by Beta” is allowed to be added to the OEM label). Alpha is the “Mfr” and “UDI Labeler” and Beta is the “Distributor.”

Can Alpha Company label its product replacing the Alpha logo with the Beta logo on the label with part number and all else staying the same and not have to get a new UDI? Label would state Manufactured by Alpha and Distributed by Beta with Beta's logo and Alpha's part number and UDI.

Trying to figure out if Beta would need to get it's own UDI in this circumstance.

Thanks!

Marcus

Marcos – It is my understanding the FDA would “allow” your UDI scenario as described above. Alpha would remain the “Mfr” and “UDI Labeler” and Beta the “Distributor” with no UDI responsibilities. Though slightly different than the FDA “default model,” FDA realizes there are many business and distribution relationship in the medical device industry.

Gary gsaner@reedtech.com

Hi everyone. I hope you don't mind me re-opening this conversation thread. I am faced with a very similar question to Danny's above but have questions specifically around agreements with the contract manufacturer.

As a summary:
1. Company X will purchase product from Factory A. (Factory A is FDA registered).
2. Products will be stored in a warehouse facility belonging to Company X.
3. Company X is also FDA registered.
4. Company X will distribute the products to Retailer Y who will sell the product in their retail outlets under the Retailer Y brand.

Based on this, I have the following questions (some have been answered already based on the information above):
1. How should the products be labelled --> answered
2. How should the products be registered on the FDA website?
3. What sort of agreement does Company X need with Factory A?
4. Who would be the manufacturer from the point of view of the FDA?
5. Any other things to consider?

It is important to note that Company X already has another range of Class 1 devices in retailers already under the Company X branding.

I appreciate your guidance.

Hello all. Interesting thread. I was wondering if one of you could assist me. I have a class 1 medical device that I own label in the UK and I am really keen to register it/my business with the FDA. I would be classed as a relabeler. Am I right in thinking that I do not need to provide the manufacturers details just my own company details as we take responsibility for sterilisation and completely relabel the product with no information about the manufacturer on the new packaging. We take manufacturers responsibility in terms of adverse events, compliance, sterilisation and labelling requirement we just do not physically manufacture it.
Thanks Claire

Hi Claire. Unfortunately, I don't have enough information to answer your question. Relabelers do not sterilize products generally. Therefore, your arrangement sounds more like you are the manufacturer and your supplier is the contract manufacturer. If it is a class 1 device, there may be no design requirements for either party. To schedule a call with me, please use the following calendly link: https://calendly.com/13485cert/30min

I'm working with an FDA compliant manufacturer who is overseas called CEM. They are the OEM and are also already importing their goods from overseas to the US with all the correct paper work; FDA ,CE, FCC etc. They are distributing in the US under their own name CEM. I have built a relationship with them and they have given me the opportunity to sell one of their products in the US under my own brand name.

In an article I believe to be written by Robert it says, "There is no formal process for “getting a private label.”

The entire private label process is negotiated between the distributor and the OEM with no involvement of the FDA. However, in the listing of devices within the FDA FURLS database, all brand names of the device must be identified. Therefore, the OEM will need to add the new brand name used by the distributor to their own listing for the 510(k) cleared product. However, the FDA does have the option to keep this information confidential simply by checking a box in the device listing form."

So my question is if the OEM adds my brand name do I still need to do any type of FDA registration?

I'm also wondering in my situation if I even need to do any kind of FDA registration at all. I'm not changing anything on the label or product at all other than the small company logo. The CEM is going to be changing the logo overseas for me, so we're only concerned this will cause issues with customs during import.

I'm open to any suggestions. I really do not want to spend a lot of money with the FDA if its not necessary in my situation.

Great question Philip. As the initial importer of the device, you should already be registered with the FDA. You would simply add the listing to your existing registration. As a private labeler, the product labeling should say, "Manufactured for" or "Distributed by" and then your company information. However, the FDA will treat you as the initial importer--not the manufacturer. If you intend to handle complaints, repackage/relabel, then you will need to add those roles to your registration. You only register once per facility, and you check the box for each role you perform.

Good day, i read all the info, which is amazing, but still i have question. Hoping you can verify for me that for our situation i got it wright:

1. Company X is a manufacturer is selling with FDA approval, medical device class II.
2. Company Y wants to sell the same products of Company X, under its name, "distributed by Company Y", with new REF No. and no mentioning of Company X on the label at all.
3. Company X will send all the products to its own warehouse in the US, so there is no need to import them to the US, so Company Y (the private label) doesn't need to register as a importer.
4. Company X will add the REF No. to their FDA listing and also register them in Company X GUDID.
5. Company X, the manufacturer will actually do all the needed adujtments, and Company Y, the private label, doesn't need to register at all in the FDA?

Please let me know if i am correct
Thanks,
Asaf