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

hornet456

Starting to get Involved
#11
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.
Monoj, thank you for clarifying on both accounts!
 
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Emma2010

Starting to get Involved
#12
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.
1. Yes, the contract manufacturers will need to register their facility, list your device, pay the 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 a Specification Developer and Manufacturer. That kind of dual responsibility exists for a single company.

Dear Willian and Monoj,

Thank you so much for your kind sharing. Can I consult you with a similar technique question about the Listing?

We have the most same background with Hornet456:
  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, XYZ, (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 sterilize, after labeling.

  • Can ABC company be considered a "manufacturer" by the FDA definition and own the 510(k) and develop the specifications/conduct R&D?
  • Does the XYZ company have to be registered with the FDA as a manufacturer or can it be identified as a critical supplier in our QMS?
Because it is very expensive to apply for a 510(K), so XYZ company wishes that they do not need another 510(K).
Can we say that these Class II devices haven't been considered as "Finished Product" before they are sterilized?

I appreciate you very much for taking the time to read my question.
I look forward to hearing from you!

Emma
 

monoj mon

Quite Involved in Discussions
#13
  • Can ABC company be considered a "manufacturer" by the FDA definition and own the 510(k) and develop the specifications/conduct R&D
  • Yes, you can list each of the applicable device and identify the ABC Company as a "Manufacturer" as well as a "Specification Developer". You can see in the image below for such kind of dual responsibilities.
    1593397032255.png
Does the XYZ company have to be registered with the FDA as a manufacturer or can it be identified as a critical supplier in our QMS?
The XYZ company will need to register as a "Contract Manufacture" and list each type of your device they manufacture for you. They will also need to maintain the registration by paying the annual fee every year until you discontinue that particular device from commercial distribution.

Because it is very expensive to apply for a 510(K), so XYZ company wishes that they do not need another 510(K).
NO, they don't need a new 510(k) to list your device, they can simply provide your 510(k) number for the device, list your device and identify the XYZ company as the "Contract Manufacturer".

Can we say that these Class II devices haven't been considered as "Finished Product" before they are sterilized?
NO, the device manufactured at the XYZ facility is already a "Finished Device" by FDA definition. Look at the FDA definition of "Finished device" below;

21 CFR 820.3(l): 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.

So, the XYZ company must register their facility, pay the fee for registration, list your device and maintain the registration every year by paying the annual fee. However, if the XYZ company is manufacturing the devices only for the ABC company and if the ABC company wants then it is possible for the ABC company to pay the registration fee for the XYZ company. In that case, the ABC company will need to pay double of the Registration fee every year but there is no restriction in it.

By the way, the XYZ company will be visited by the FDA for Auditing purposes once the XYZ company register their facility.
 

Emma2010

Starting to get Involved
#14
  • Yes, you can list each of the applicable device and identify the ABC Company as a "Manufacturer" as well as a "Specification Developer". You can see in the image below for such kind of dual responsibilities.
    View attachment 26946

The XYZ company will need to register as a "Contract Manufacture" and list each type of your device they manufacture for you. They will also need to maintain the registration by paying the annual fee every year until you discontinue that particular device from commercial distribution.


NO, they don't need a new 510(k) to list your device, they can simply provide your 510(k) number for the device, list your device and identify the XYZ company as the "Contract Manufacturer".



NO, the device manufactured at the XYZ facility is already a "Finished Device" by FDA definition. Look at the FDA definition of "Finished device" below;

21 CFR 820.3(l): 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.

So, the XYZ company must register their facility, pay the fee for registration, list your device and maintain the registration every year by paying the annual fee. However, if the XYZ company is manufacturing the devices only for the ABC company and if the ABC company wants then it is possible for the ABC company to pay the registration fee for the XYZ company. In that case, the ABC company will need to pay double of the Registration fee every year but there is no restriction in it.

By the way, the XYZ company will be visited by the FDA for Auditing purposes once the XYZ company register their facility.
Dear Monoj,

Thank you so much for your detailed answer! That means a lot to me.

I will make sure to pass this on to my team that XYZ company will need to register their facility and need another 510(K) for the same products.

Now, I realize that even though they are almost the same products, but they need different 510(K)s for whether they are sterilized or not.

I appreciate you very much for your professional and prompt response!

I wish you all the best!

Emma
 

monoj mon

Quite Involved in Discussions
#15
Dear Emma,

I will make sure to pass this on to my team that XYZ company will need to register their facility and need another 510(K) for the same products.

Now, I realize that even though they are almost the same products, but they need different 510(K)s for whether they are sterilized or not.
I think you misunderstood my point. I said the XYZ company "DOES NOT NEED" a new 510(k) submission for your product. You are the owner of the product and the 510(k) number belongs to you. The XYZ company can simply cite your 510(k) number while listing your device and register themselves as the "Contract Manufacturer". See my original response,

NO, they don't need a new 510(k) to list your device, they can simply provide your 510(k) number for the device, list your device and identify the XYZ company as the "Contract Manufacturer".
 

Emma2010

Starting to get Involved
#16
Dear Emma,



I think you misunderstood my point. I said the XYZ company "DOES NOT NEED" a new 510(k) submission for your product. You are the owner of the product and the 510(k) number belongs to you. The XYZ company can simply cite your 510(k) number while listing your device and register themselves as the "Contract Manufacturer". See my original response,
Dear Monoj!

Thank you very much for correcting my mistake! Please forgive my misunderstanding. Now I came to realize that since we have had a 510(K) number for the product, the XYZ company needs to list our device by simply citing our 510(K) number and register themselves as the "Contract Manufacturer".

I appreciate it very much for your patient and your detailed explanation. I even can't find any word to explain my thank to you!

I wish you all the best!

Yours sincerely,
Emma
 
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