FDA Establishment registration - Buying some medical devices from another manufacturer

C

Cecilia

#1
Hello all,
The company I work for is a medical device manufacturer company, but will buy some medical devices from another medical device manufacturer (#2) to complete product portfolio for the US market.

The #2 has not registered their establishment with the FDA, but a different party, which is another customer of #2, did registered the facility, and have shared with us the registration number, we have confirmed it has an active status with the FDA.

What I would like to ask is if there will be an issue if the establishment (#2) is registered by a different party, not by the #2 itself nor by my company.

Thanks
 
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monoj mon

Trusted Information Resource
#3
I see an issue here. It's the manufacturer (#2) who must register their facility, list their devices and pay for the registration fee and maintain the registration every year; not by their customer (the customer may wish to offer the payment for the manufacturer, there is no harm in it) as when FDA will go for an audit, they will visit the facility where devices have been manufactured. FDA's definition of "Manufacturer";
1590110036104.png

And to my understanding, there is no such provision to "register" a facility on behalf of someone!

1590110738288.png
But in your case, if the "other customer" of "manufacturer #2" has some legal relationship and the customer legally owns the facility of the "manufacturer#2" in some way, then the customer can register the "facility" of the "manufacturer #2" on their behalf.
 
Last edited:
C

Cecilia

#4
I see an issue here. It's the manufacturer (#2) who must register their facility, list their devices and pay for the registration fee and maintain the registration every year; not by their customer (the customer may wish to offer the payment for the manufacturer, there is no harm in it) as when FDA will go for an audit, they will visit the facility where devices have been manufactured. FDA's definition of "Manufacturer";
View attachment 26845

And to my understanding, there is no such provision to "register" a facility on behalf of someone!

View attachment 26846
But in your case, if the "other customer" of "manufacturer #2" has some legal relationship and the customer legally owns the facility of the "manufacturer#2" in some way, then the customer can register the "facility" of the "manufacturer #2" on their behalf.
Thank you for your response!

This is what I thought; no, the "other customer" does not owns the facility, they are only managing the establishment registration with the FDA.
Since they are a customer of "manufacturer #2" and competitor of my company, and they are paying for the annual registration, they are no letting listing new brands under this facility (manufacturer #2). And this is the real issue, right?
 

William55401

Quite Involved in Discussions
#5
If a competitor customer controls Registration and Listing on behalf of the shared manufacturer, I agree that this is challenging. If you haven't, I would certainly escalate this issue for resolution. Please be aware there are Registration and Listing service providers that your shared manufacturer could rely on instead. That may be a better solution. Good luck
 

monoj mon

Trusted Information Resource
#6
Thank you for your response!

This is what I thought; no, the "other customer" does not owns the facility, they are only managing the establishment registration with the FDA.
Since they are a customer of "manufacturer #2" and competitor of my company, and they are paying for the annual registration, they are no letting listing new brands under this facility (manufacturer #2). And this is the real issue, right?
WOW, never heard case like that :bonk:. Without having any legal ownership, the "Customer" is controlling the Manufacturer#2. Why did the "Manufacturer#2" let it happen at first point! Didn't they realize that at some point they would get more new customers and would eventually expand! This is really a big issue, only thing you could do (as William has said) is just negotiate with both the parties or just simply change to a "Manufacturer #3" :sneaky:.
 
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