Contract manufacturer FDA requirements foreign company

#1
Dear all,

My company (established in the Netherlands) is preparing to act as a contract manufacturer for an international company. This company (customer) is planning to distribute the medical devices (finished devices) that we produce on customer's specification, within the U.S. market.

The finished device is a class I medical device (accessory) by Regulation number 878.4800.

What are the exceptions to Subchapter H (Medical Devices) of the FDA when acting as a contract (foreign) manufacturer? Do we need to review all parts of subchapter H on applicability? Or just the articles which are specifically written with regard to foreign (contract) manufacturers? Such as §803.58 where you need to designate a U.S. agent to be responsible for reporting in accordance with §807.40 of that chapter.

Please let me know what our responsibilities are as a contract manufacturer in the US market.
 
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monoj mon

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#2
Perhaps, we would need some more information to answer properly. Such as, you will contract manufacture the device and your partner company in the US will distribute it, then who will be the "Manufacturer" with legal responsibilities on the product (I mean whose name will be placed on the label next to the "Manufacturer" symbol?). If I guess you will put your name as the "Legal Manufacturer", then in addition to the applicable sections from §803, you will also need to review the applicable section from §801, §806, §807, §820, §830 etc. However, if you are just acting as Contract Manufacturer and someone else will have the legal responsibilities on the devices, then you will have limited obligations such as §807, §820 etc.

In any case, you will need to assign a US agent, register your facility by paying the fee, list the device you have manufactured for your partner in the US and maintain the registration every year. If you are just a contract manufacturer, then you will need to wait until the legal manufacturer list the device before you are eligible to list that particular device. Once you register your facility you can expect FDA inspecting your facility in the near future.
 
#3
Thank you for your reply!

We shall act as a "supplier" to the company. The company shall be the manufacturer with the legal responsibilities.
In that case, you have mentioned that we only have limited obligations such as §807, §820 etc.

Could you or someone else here please explain to me how I can find these mandatory requirements? How do I know it concerns a requirement only for the contract manufacturer as the "supplier"? Should I just follow the requirements for a (foreign) "supplier" and ignore the requirements for a manufacturer, as we will not act as a "legal manufacturer"? I hope someone can clarify this for me.

Thank you very much in advance!
 

monoj mon

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#4
We shall act as a "supplier" to the company. The company shall be the manufacturer with the legal responsibilities.
I think you are confused with the word "Foreign" and "supplier", for instance I would advice you to forget the words "Supplier" and "Foreign Supplier or Foreign Manufacturer". Being a "Foreign Establishment", when it comes to listing the device you are selling to the "company", there won't be such "supplier" activity in the FDA database. You will need to choose one from this list. You can go to the definitions of these and see which one suits you.
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that we produce on customer's specification, within the U.S. market.
You manufacture a finished device based on someone's specification, that makes you a "Contract Manufacturer". From that point of view, the regulation requires you to follow at least the sections §807 and §820 and it does not matter you are inside the US or outside the US. Only difference will be, you are required to assign a US Agent. Let me give you some hypothetical scenario.

Scenario 1: A foreign company "A" manufactures a "finished device" and a US company "B" distributes that device in the US market. The labeling states "Manufactured by A" and "Distributed by B". So, company A registers their facility and list the device for the activity as "Manufacturer" and assigns a US agent. Company A decides the content of the "Labeling". It does not make any difference if company A is in the US or outside the US. Whenever FDA receives any complaint about the device, they contact the "US Agent " of Company A and Company A is required to do the necessary actions. Additionally, Company A performs "PMS" activity and takes the necessary actions after the PMS. In this case Company A is the "Legal Manufacturer" and follows the sections §801, §803, §806, §807, §820, §830 etc.

Scenario 2: A foreign company "A" manufactures a "finished device" for a US company "B" by following their specifications. The labeling states that "Manufactured For B" and "Manufactured by A". So, company A registers their facility and list the device for the activity as "Contract Manufacturer" and assigns a US agent. In this case also, it does not matter if the company A is in the US or outside US. But, in this case, Company B decides the content of the "Labeling" and whenever FDA receives any complaint about the device, they will contact the "Company B" and "Company B" is required to take the necessary actions. Additionally, in this case, the Company B performs the "PMS" activities and takes the necessary actions after the PMS. In this case, Company B is the "Legal Manufacturer" and follows the sections §801, §803, §806, §807, §820, §830 etc. while the Company B is the "contract manufacturer" and follows at least the sections §807 and §820.

In both the Scenario, FDA will inspect the "foreign establishment" frequently and will check (at least) how it is in compliance with §820. And if Company A doesn't follow §807, it will be a strong violation and the shipment won't even be able to go through the US custom.

We are also a foreign "contract manufacturer" for US clients. I make sure that we are (at least) in compliance with all the Sub-parts of the Part §820 (Quality System Regulation). Also I make sure that we have "One US agent", "Register our Establishment", "List the device to be sold" and "Identify our activities for each and every device to be sold".

I hope this makes sense to you.
 
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#5
Thanks a lot for your explanation. As you have noticed, I am struggling with reviewing the FDA ;) In my opinion the US/FDA mindset is quite different from the EU/MDR mindset.

For me it was apparently unclear what role we fulfilled as "contract manufacturer". The only information given to me is that we will be the contract manufacturer and we will act as the "supplier" to the customer, who in turn will act as the legal manufacturer when distributing our finished goods (on customer's specifications) in the U.S. market. That's how the customer explained it to us. Perhaps not to scare us off? We are a small company (with few resources) and are therefore not eager to go outside the EU market.
However, we are willing to think along with them, in the end we will also grow if we are FDA ready (as a contract manufacturer). However, we don't want to face any surprises!

Hence my question which requirements we need to comply with as contract manufacturer and how I can recognize these requirements in the law (FDA).
You now made clear that I need to forget the words "Supplier" and "Foreign Supplier or Foreign Manufacturer" and which parts may apply. Thanks again! However, I still find it difficult to recognize in (Subchapter H of) the FDA in which role which parts will apply.

Anyway, I am glad to have found this forum from which I learn a lot!
 

monoj mon

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#6
You need to first ask your partner in the US who will officially control the content of the labeling (IFU+Label)! Sometime, some big companies just want to play the role as "Distributed By" only as they have too many products to maintain and let the original company have the full responsibility/control on the product. So, first make sure who will be what by using the above two scenarios!
However, we don't want to face any surprises!
FDA will go for facility inspection, that is quite certain. May be not this year, or next year but will go at their convenience. However, in most cases, FDA provides prior notification of their visit along with their schedule.
We are a small company (with few resources)
You will need to pay the registration fee for your facility every fiscal year and it is independent of the device you are selling, whereas the listing of device is free. That means, with one single registration you can list multiple products for multiple clients.
However, I still find it difficult to recognize in (Subchapter H of) the FDA in which role which parts will apply.
For now you may just focus on §820 and §807 (considering you as a contract manufacturer) and let's see if other users here have anything more to suggest.

By the way (assuming you don't have it), get a Employer ID Number and DUNS number first. You will be needing it if you are entering into the US market. If you already have it, then it's great.
 
#7
Regarding the pay registration fee, our partner is willing to reimburse these costs. From the moment we also enter the U.S. market for other customers we shall pay this fee by ourselves.

You are right about not having an Employer ID Number and DUNS number yet. We take this into account in our preparations.

I keep repeating myself, but thanks again ;) This helps me a lot!
 
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