Who should be listed as the manufacturer/distributor on the box?

[hornet456]

Hello All,

Please bear with me as i'm slowly learning the complex ropes of US FDA QSR on medical devices.

1. We are a US medical device company (ABC company) and are listed with the FDA as the "manufacturer".
2. We have a 510(k) on our class II medical device and traditionally have a "critical supplier" in china (who is ISO 13485:2016 certified and who we have a quality agreement with) make our device, which is then shipped to our facility in the US and subjected to quality testing etc. before finally being assembled into a box with accessories and DFU/IFU.
3. In this traditional relationship we are listed on the box as the manufacturer and the FDA has been happy with it in our last two audits.
4. We are now in discussions with a third party (XYZ company) in the US who is interested in marketing our device. To meet initial volume, we are interested in ideally having our critical supplier in china finish the assembly portions of the device as well and ship the packaged device directly to the distributor in the US. My questions to the peers in this forum are as follows:

• Who can/should be listed as the manufacturer on the box?
• Since the FDA allows either the distributor or manufacturer to be listed on the box, is it possible to list XYZ company as the distributor on the box? If not, can ABC company be listed as the distributor?
• Can ABC company still be considered a "manufacturer" by the FDA definition since we own the 510(k) and develop the specifications/conduct R&D?
• If the critical supplier in china starts to package the device, do they have to be registered with the FDA as a manufacturer instead of being identified as a critical supplier in our QMS?

I appreciate your patience in reading this post and any insights that you can provide will be greatly appreciated. Thank you for your time.

 

[William55401]

I believe your China manufacturing partner needs to register and list right now as they ship you a functional finished device. Here's an excerpt from QSR definitions....

Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Your firm is already testing and packaging the China finished device. Testing that you perform, while important, does not matter per the FDA definitions. The device functions when it leaves their plant.

Your China supplier is a foreign establishment and a contract manufacturer (CM) who is subject to Registration and Listing. Here's FDA definition of Contract Manufacturer - Manufactures a finished device to another establishment's specifications. I suggest you search on US FDA Who Must Register and List. Look at the Foreign Establishment section.

Question 4. Clarifying questions. Who will brand the product? Will the package still show ABC or will your new partner XYZ brand the product?

 

[hornet456]

William,

Thank you for your detailed response and for advising me on the FDA registration aspect for our contract manufacturer. I'll make sure to pass this on to our team.

As for branding regarding Question 4, that remains to be negotiated but the ideal goal would be brand XYZ with either "powered by ABC" or "XYZ inside" etc. We would remain amenable to retaining the brand as ABC but would prefer the former option.

Thank you.

 

[monoj mon]

One small input besides what William has said. Your first question was

Who can/should be listed as the manufacturer on the box?

You are asking who should be designated as the manufacturer on the "Label", not in the FDA database. If the company ABC wants to be designated as a manufacturer and your Chinese partner doesn't want to appear on the label then simply put the "Manufactured For ABC" and "Distributed by XYZ Company". While listing your device in the FDA Database,

1. Ask your Chinese partner to list your device as "Contract Manufacturer",
2. For the ABC company list the device as "Specification Developer" (if that is true in your case)
3. The XYZ company does not need to register their facility or list your device as it is a domestic establishment.

 

[hornet456]

One small input besides what William has said. Your first question was


You are asking who should be designated as the manufacturer on the "Label", not in the FDA database. If the company ABC wants to be designated as a manufacturer and your Chinese partner doesn't want to appear on the label then simply put the "Manufactured For ABC" and "Distributed by XYZ Company". While listing your device in the FDA Database,

1. Ask your Chinese partner to list your device as "Contract Manufacturer",
2. For the ABC company list the device as "Specification Developer" (if that is true in your case)
3. The XYZ company does not need to register their facility or list your device as it is a domestic establishment.

That is exactly what i'm asking, thanks for the clarification! With regards to your comments on the FDA database aspect:

1. When you say ask the Chinese partner to list the device as "contract manufacturer", do you mean ask them to register their facility with the FDA and pay the annual registration fee? If so, this should be easily done. However would they then necessarily have to undergo FDA audits despite having an ISO 13485:2016 certification?
2. ABC company (our company) is indeed the "specification developer" since we conduct all the R&D/clinical studies etc. However we would still want to retain some assembly aspect of the manufacturing for smaller orders and international clients etc. I'm hoping that this dual relationship is possible.
3. It is good to know that the XYZ company does not need to register their facility with the FDA, being a domestic entity.

Thank you for your time.

 

[William55401]

1. By registering with US FDA, the China contract manufacturer (CM) becomes known and is subject to FDA oversight including audits. 13485 is a great start for their QMS. As a supplier to your firm, you are responsible for oversight of this CM per Purchasing Controls.
2. If you perform some manufacturing, you are no longer a specification developer but a manufacturer.
3. Yes, distributors do not need to Register and List.

 

[hornet456]

1. By registering with US FDA, the China contract manufacturer (CM) becomes known and is subject to FDA oversight including audits. 13485 is a great start for their QMS. As a supplier to your firm, you are responsible for oversight of this CM per Purchasing Controls.
2. If you perform some manufacturing, you are no longer a specification developer but a manufacturer.
3. Yes, distributors do not need to Register and List.

William,

Points 1 and 3 are great to know.

As for point 2, my understanding from your explanation is that it is possible for our company to be considered a manufacturer (if we perform some manufacturing) despite having a contract manufacturer. Is that accurate?

Thank you for your time.

 

[William55401]

I based my response on what you disclose. You state "retain some assembly aspect for small orders...." that sounds like manufacturing to me. I once had a client that was a true spec developer. They were housed in an office building with no production facilities. Design control in USA. Manufacturing partners in Asia and in the USA. When designing their QMS, it was important for no mfg to occur at their facility to minimize regulatory compliance risk related to Production and Process Controls. We listed as a Spec Developer and had to stay within our definition. Purchasing controls of the supply chain was a key element of the QMS.

 

[monoj mon]

That is exactly what i'm asking, thanks for the clarification! With regards to your comments on the FDA database aspect:

1. When you say ask the Chinese partner to list the device as "contract manufacturer", do you mean ask them to register their facility with the FDA and pay the annual registration fee? If so, this should be easily done. However would they then necessarily have to undergo FDA audits despite having an ISO 13485:2016 certification?
2. ABC company (our company) is indeed the "specification developer" since we conduct all the R&D/clinical studies etc. However we would still want to retain some assembly aspect of the manufacturing for smaller orders and international clients etc. I'm hoping that this dual relationship is possible.
3. It is good to know that the XYZ company does not need to register their facility with the FDA, being a domestic entity.

Thank you for your time.

1. Yes, contract manufacturer will need to register their facility, list your device, pay annual fee and get ready for any future FDA inspection. We are ISO13485 certified company but still FDA audits us regularly.

2. It is still possible to register your facility as Specification Developer and Manufacturer. That kind of dual responsibilities exists for a single company.

 

[hornet456]

I based my response on what you disclose. You state "retain some assembly aspect for small orders...." that sounds like manufacturing to me. I once had a client that was a true spec developer. They were housed in an office building with no production facilities. Design control in USA. Manufacturing partners in Asia and in the USA. When designing their QMS, it was important for no mfg to occur at their facility to minimize regulatory compliance risk related to Production and Process Controls. We listed as a Spec Developer and had to stay within our definition. Purchasing controls of the supply chain was a key element of the QMS.

William, thank you for the excellent clarification! It does sound like we will be considered a manufacturer.