Establishment Register Question - Subcontracting - Blood Glucose Monitor System

C

celia4237

#1
I want to discuss the following situation with all of you, how to do the establishment register?

Company A locates in address X, where it doesn't manufacture. Instead, company A rent one building of Company B to produce the blood glucose strips. moreover, company B manufactures blood glucose meter for company A, then company A sell the whole blood glucose monitor system.

Now the company A need to register in FDA.

I want to know who is the owner/operator, the address of the owner/operator. who is the manufacturer, the address of the manufacturer.

Company B must be the contracted manufactuer of company A, and company A should include this information when register the establishment?

Thank you.
 
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W

wangyang

#4
I am still confused, i think company A in address X should be the owner/operator, and company A in the rented address should be the manufcturer.

Right?
 
B

Bunbury

#5
Hi Celia

If we are talking about two separate companies:

  • Company A must register as the legal manufacturer and is the specification developer on the device listing. If headquarters, they are their owner/operator. If not, they have another owner/operator within the company.
  • Company B must register as a contract manufacturer and may use the 510(k) number from Company A. They will have their own owner/operator within their company.
(That said, I have heard some rumblings from a contract mfg that the FDA is considering looking at some of the contract mfg.s as "component mfg.s" instead of "actual" manufacturers. Until I hear the word, I suggest following the old tried and true.)

If we are talking about two branches of the same company:

  • Company/Branch A, see above.
  • Company B/Branch, registers as a manufacturer on their device listing and uses the same 510(k) no. as Co. A. Their owner/operator is within the Company A organization -- probably Co. A.

Shawn
 
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C

celia4237

#6
Company B must register as a contract manufacturer and may use the 510(k) number from Company A. They will have their own owner/operator within their company.
Why company B can use the K number of company A?
 
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B

Bunbury

#7
Why company B can use the K number of company A?
Chances are good that Company B is strictly a contract manufacturer and has no 510(k) of its own. It is manufacturing another company's product to spec and will list this on its device listing.

The Establishment Registration is a declaration of what the company does and is permitted to do. A company (Company A) might be the specification developer for products X and Y but only manufactures X itself. So on its device listing, it is the spec developer for X and Y and the mfg for X.
They farm out Y to another company (Company B), which registers as a contract mfg. for product Y.

Now if Company B also has its own product Z for which is is the spec developer, its device listing will show that as well. So they will show both Y (contract mfg) and Z (spec developer) on their listing.

If anyone can explain it better, I'd appreciate it.
Thanks.
 
W

wangyang

#8
Hi Celia

If we are talking about two separate companies:

  • Company A must register as the legal manufacturer and is the specification developer on the device listing. If headquarters, they are their owner/operator. If not, they have another owner/operator within the company.
  • Company B must register as a contract manufacturer and may use the 510(k) number from Company A. They will have their own owner/operator within their company.
Shawn
What if company A also outsource the design activities of blood glucose monitor to company B? Can company A submit the 510(k) of the blood glucose system (the meter and the test strips)? where should the design history file be stored?
 
L

Laura Halper

#9
Hello,
I'd like to clarify that Company B may or may not need to Register and List as a contract manufacturer. The FDA used to require that all contract manufacturers Register and List. But they changed this requirement a while back. Now, only contract manufacturers who ALSO distribute the device for the specification developer must Register and List.

It sounds like Company A distributes this particular glucose monitoring system. If Company B does NOT distribute the product, but is just the contract manufacturer, then Company B does not need to Register nor List.

Regards,
Laura
 
B

Bunbury

#10
The FDA used to require that all contract manufacturers Register and List. But they changed this requirement a while back. Now, only contract manufacturers who ALSO distribute the device for the specification developer must Register and List.
Hi Laura,

Thanks a lot for this information. This is probably what our contract manufacturer was talking about, but when I asked for a specific reference, he couldn't point to it. Do you happen to know more about it? What if they "distribute" it to one of our overseas warehouses?

We would have a real problem if our 3rd party manufacturers didn't register simply because it would be unacceptable to some other countries' ministries of health and would make registering products much more difficult.

Regards,
Shawn
 
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