Does my firm need to list a Contract Manufacturer under Establishment Listing?

A

Arnthor

#1
Dear all,

My firm is a maunfacturer of medical device for US market. Recently my management is trying to outsource part of the production line to an contract manufacturer. This process is rather complicated and I need some advice.

My firm had a sister plant located in a another country and this sister plant will manufactured a WIP (Work In Process) part of a medical device. Then it will ship to a contract manufacturer to completed the entire medical device.

After completion of the finished medical device, the contract manufacturer will shipped the finished device back to my firm for sterilization and final inspection.

My firm sister plant was registered under my firm US FDA establishment listing.

So my question is, does my firm need to register the contract manufacturer under by my firm establishment listing? Or they have to register with US FDA themselves?


Please advice.

Arnthor
 
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somashekar

Staff member
Super Moderator
#2
Re: Does my firm need to list an contract manufacturer under establisment listing?

The contract manufacturer must be advised to register with US FDA themselves, as they are the manufacturers of the medical device going into USA.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Does my firm need to list an contract manufacturer under establisment listing?

After completion of the finished medical device, the contract manufacturer will shipped the finished device back to my firm for sterilization and final inspection.
Hi,

According to my understanding (see also http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm), if the device is also to be sold in the USA in the non-sterile state (as supplied by the contract manufacturer) then it may be in the grey area and the contract manufacturer may be required to register. Otherwise the product they supply to you is not a finished medical device, and therefore they will not be required to register. Additionally, as far as I understood they don't ship their finished product to the USA = not required to register.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#4
Re: Does my firm need to list an contract manufacturer under establisment listing?

That is a good link of FDA Ronen ...
Foreign Establishments
Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer.
Register : YES 807.40(a)
List: YES 807.40(a)
Pay fee: YES

My basis was on this and the 807.40(a) as below :

Sec. 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
(a) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register and list such devices in conformance with the requirements in subpart B of this part unless the device enters a foreign trade zone and is re-exported from that foreign trade zone without having entered U. S. commerce. The official correspondent for the foreign establishment shall facilitate communication between the foreign establishment's management and representatives of the Food and Drug Administration for matters relating to the registration of device establishments and the listing of device products.
(b) Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.
Sterilization is addressed as a seperate activity.
You could be the agent in USA perhaps for this contract manufacturer

See the entire 21CFR807 Here
 
M

MIREGMGR

#5
Re: Does my firm need to list a Contract Manufacturer under Establisment Listing?

Somashekar, I respectfully believe your analysis is incomplete.

First, generally outside-US contract manufacturers do not have to Register if the product they make is not legally a medical device when they ship it. 21CFR807.40 applies only to device makers...a term with legal meaning. 21CFR807.65 exempts from the 21CFR807.40 outside-US Establishment Registration requirement those outside-US contract manufacturers that make something other than a legally defined medical device...such as a component or subassembly, per exemption 21CFR807.65(a).

I don't think the OP has provided us with enough information for us to definitely know whether the contract manufacturer's product is a device when they ship it. If the product can only be used in sterile, pouched, labeled form and is shipped bulk nonsterile, unpouched and unlabeled, it may well not yet be a medical device.

Second, under the usual interpretation of the FD&C Act, while a medical device is required to be Listed, Listing the same device more than once is prohibited. The Lister must be the responsible Establishment, and each device can only have one Establishment legally responsible for it. If the outside-US contract manufacturer does not make legally defined medical devices, there are three legal reasons why they cannot List those products: the component- or subassembly-products are not medical devices, the contract manufacturer is not a Registered Establishment, and the company to which they sell their component- or subassembly-products is the responsible Establishment.
 
Last edited by a moderator:
A

Arnthor

#6
Re: Does my firm need to list a Contract Manufacturer under Establisment Listing?

Hi guys,

Thanks for all the information.

I would like to add a bit more detail.

The medical device manufactured by my contract manufacturer is a complete medical device. However sterilization is needed before it can be release into US market. (The finished medical device is a sterilized device)

The contract manufacturer shipped the medical device to my firm (non US firm) for sterilization and QA inspection. Then my firm will shipped the medical device to US.

So does my contract manufacturer need to register/list/pay to US FDA? If yes, does it subject to FDA inspection? My contract manufacturer is a certified ISO 13485 plant.

As for my firm current establishment listing, both my firm and my sister firm listed the same medical devices. In the past, my firm manufactured this device and was shifted to my sister firm two years ago (that the reason why my firm listed my sister firm in my firm establishment listing).

Now my management want to shift part of the manufacturing processv from my sister firm to a contract manufacturer. So that created a lot of questions for me.

Best regards,

Arnthor
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Does my firm need to list a Contract Manufacturer under Establisment Listing?

So does my contract manufacturer need to register/list/pay to US FDA? If yes, does it subject to FDA inspection? My contract manufacturer is a certified ISO 13485 plant.
Once again, given the described arrangement is strictly adhered to (no corner cutting or rule bending in the future), I think your CM does not need to register as they will not ship their product (be it a legal medical device or not) into the USA, and they will of course not distribute it commercially within the USA. Refer back to the link I provided before.

FDA inspection considered, as a non-registered establishment they will not be on the FDA inspection schedule; however, in certain circumstances FDA inspectors may wish to inspect your CM premises as part of YOUR FDA inspection (as you are registered you ARE on the FDA schedule).

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#8
Re: Does my firm need to list a Contract Manufacturer under Establisment Listing?

More clarity with the post #6 of Arnthor. Be sure to keep good outsourced process control over your CM and ensure you he has a good product release procedure that meets your requirement and that he provides all essential device history records and maintains ongoing validity of necessary process validations and his ISO 13485 certification.
 
C

csterling

#9
Re: Does my firm need to list a Contract Manufacturer under Establisment Listing?

Hi;

I have a question somehow related to this topic.

I work for a foreing (out of the USA) Contract Manufacturer and are listed with the FDA. I would appreciate if I can get feedback on the difference between a Medical Device Manufacturer and a Contract Medical Device Manufacturer.

The reason I am asking is because during our recent ISO 13485 re-certification audit, the Auditor suggested that we shall not consider our firm as a finished medical device manufactuer although we are shipping sterilized medical devices to our customers in the USA.

The Auditor also added that there are 3 basic reasons for not considering us as a finished medical device manufacturer:

1- We are a Contract Medical Device Manufacturer, not a Medical Device Manufacturer.

2- We are not responsible for the distribution of the product

3- Finished Medical Device applies only to the MDD (owner or legal manufacturer of the product

Thanks in advanced for all the feedback and references.
 
M

MIREGMGR

#10
Re: Does my firm need to list a Contract Manufacturer under Establisment Listing?

...during our recent ISO 13485 re-certification audit, the Auditor suggested that we shall not consider our firm as a finished medical device manufactuer although we are shipping sterilized medical devices to our customers in the USA.
With regard to USA activity:

Are your customers the end users of the devices, or perhaps a layer of distributors/dealers (not Registered with the FDA as Manufacturers or Specification Developers) who sell to end users? Or, do you instead sell to one or more companies that are Registered with US FDA as Manufacturers or Specification Developers, that then market the devices (directly or through a further stage of distributors/dealers) to end users? If your situation is the first scenario, you are the responsible Manufacturer. If it's the second scenario, you're probably a contract manufacturer.

who Lists the devices with US FDA? If it's your customers, you're a contract manufacturer.

The Auditor also added that there are 3 basic reasons for not considering us as a finished medical device manufacturer:

1- We are a Contract Medical Device Manufacturer, not a Medical Device Manufacturer.
Do you have a Supplier Agreement with your customers that defines this, or does it state this on the Purchase Orders they issue to you? Your status is definitively established by your contracts, as long as the result is that a competent responsible party is defined. A medical device must have one responsible party...not two, but also not zero...so contracts may not be definitive if they would act to create a two or zero situation.
 
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