FDA Medical Device Registration - Scenario - Two Companies

I

IDENT12345

#1
I need some guidance on the following scenario....

Company "A" is a foreign ISO approved company and manufacturers a class I device known as XXX. Company "A" is the product specification owner of XXX and is registered with the FDA as a class I device. Company "B" is located in the US and has asked company "A" to manufacture device XXX and label it with company "B" name and change the device name YYY. In addition, company "B" has requested the menu on the device be changed. Once product labeling is complete, company "A" will package the product and label the packaging with company "B" name. The product will be shipped to company B in the US and warehoused until distribution (w/in and outside US). :bonk:

Question:
1.) Is company "B" considered a an initial importer, relabeler, or specification developer for device YYY?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I need some guidance on the following scenario....

Company "A" is a foreign ISO approved company and manufacturers a class I device known as XXX. Company "A" is the product specification owner of XXX and is registered with the FDA as a class I device. Company "B" is located in the US and has asked company "A" to manufacture device XXX and label it with company "B" name and change the device name YYY. In addition, company "B" has requested the menu on the device be changed. Once product labeling is complete, company "A" will package the product and label the packaging with company "B" name. The product will be shipped to company B in the US and warehoused until distribution (w/in and outside US). :bonk:

Question:
1.) Is company "B" considered a an initial importer, relabeler, or specification developer for device YYY?
Within the US, "B" could be an Initial Importer, distributor and maybe Complaint Handler, if that's so arranged. In that case, "A" is the Manufacturer, and the device is subject to the FDA Private Labeling rules.

Or, within the US, "B" could be a Specification Provider and Initial Importer if they wanted to take regulatory responsibility for the device, in which case "A" would be a Contract Manufacturer.

In the first scenario, exports to the EU and Australia would be at least inconvenient, because the players' regulatory stances would have to be different in those regulatory jurisdictions.

In the second scenario, assuming that "B" has a CE Mark and an EU Representative, "B" could direct "A" to apply that CE Mark and other appropriate information to the device labeling, and export to EU and Australia would be straightforward.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
and export to EU and Australia would be straightforward.
Just to highlight that a CE mark in itself is not sufficient for export to Australia; an ARTG Inclusion would be required as well. The process for Including a properly CE-marked device is quite straightforward, indeed.
 
I

IDENT12345

#4
Thanks. The device is already CE marked by company "A" and company "B" would follow FDA label requirements, so the label would indicate "Manufactured for company "B". Wouldn't CE mark apply to company "B" device since company "A" already has CE mark? Can you point me to a reference? Thanks
 

Sarah Stec

Involved In Discussions
#5
The CE Mark from Company A wouldn't apply to Company B. If Company B wants to CE-Mark the product and ship the product as their own with their own labeling, then they would need to get their own CE Mark. CE marking isn't transferable. In this instance, it sounds like Company B may be able to CE-OBL via Company A. But first you may want to examine how much the Company B-ordered menu changes the device from the CE-marked one from Company A to a different device that isn't covered by Company A's tech file. :agree1:

See: the MDD and its definition of "manufacturer."
 
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