Medical Device and Accessory Establishment Registration and Listing Query

R

redknight07

#1
Fellow members of the cove, hope you can assist me in addressing this query regarding registration and listing:

Company ABC manufactures device X (class II). As part of device X, it uses two accessories which are classified as devices (one is class I and the other is class II) and are both manufactured by company LMN. Company ABC and LMN are both located within the US. The two accessories are used as per their intended use. If company ABC is just distributing these accessories, which happen to be devices, as part of the device X as well as separately and the label mentions specifically that company ABC is the distributor then does company ABC require to register and list these two devices with the FDA?

The devices are labeled at the facility of company LMN and state that company ABC are the distributors for those two devices. The label also includes part number assigned by ABC-the distributing company.

Does Company ABC then fall under the category of “Distributors that don’t import devices” and hence does not require registration and listing?
Or since the label includes the part number as assigned by the distributing company, they are hence considered as the relabeler?

http://www.fda.gov/MedicalDevices/D...istrationandListing/ucm053165.htm#definitions

Appreciate any feedback. Thanks.

Regards,

Aniket
 
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M

MIREGMGR

#3
A terminology point: ABC, as the regulatorily responsible Manufacturer of X, presumably already is a Registered Establishment, and has a Listing for X. So, the question only has to do with whether ABC has to have Listings for Accessory 1 and Accessory 2.

Fundamentally, all marketed devices must be Listed by a Registered Establishment, and the role-allocation for a Listed device must be logical, i.e. a device can have one Manufacturer, or one Specification Provider plus one Contract Manufacturer. If Accessory 1 and Accessory 2 are each Listed by LMN, and LMN states that their role is Manufacturer, then ABC does not need to List them. If LMN states that their role is Contract Manufacturer, and there is no other Specification Provider, then ABC must List as Specification Provider and the labeling that says "Distributor" is incorrect.

In my view, "Relabeler" doesn't apply except in situations where the party involved actually re-labels, and the new label has significantly different content. Per your description, I don't see how that would apply.

In gray area situations like this, it's appropriate to have a Memo to File that describes your analytical process in regard to each of the possibly applicable approaches, so that in the event of an inspection you can show how you arrived at what you're doing.
 
R

redknight07

#4
Thank you MIREGMGR for your feedback, in response to your post:



A terminology point: ABC, as the regulatorily responsible Manufacturer of X, presumably already is a Registered Establishment, and has a Listing for X. So, the question only has to do with whether ABC has to have Listings for Accessory 1 and Accessory 2. Correct: ABC is a Registered Establishment and has listing for X.

Fundamentally, all marketed devices must be Listed by a Registered Establishment, and the role-allocation for a Listed device must be logical, i.e. a device can have one Manufacturer, or one Specification Provider plus one Contract Manufacturer. If Accessory 1 and Accessory 2 are each Listed by LMN, and LMN states that their role is Manufacturer, then ABC does not need to List them. If LMN states that their role is Contract Manufacturer, and there is no other Specification Provider, then ABC must List as Specification Provider and the labeling that says "Distributor" is incorrect.
Accessories 1 and 2 are each listed by LMN. LMN manufactures 1 and is a repackager/relabeler for 2. These accessories are labeled by LMN at their facility and includes the statement “Distributed by: ABC” and then the package is sent to ABC. ABC does not modify the package. It is sold with the device X and also separately.

In my view, "Relabeler" doesn't apply except in situations where the party involved actually re-labels, and the new label has significantly different content. Per your description, I don't see how that would apply.
As per definition of relabeler, since ABC does not change the content but just adds its name, it seems to be non-applicable.
As per definition of r[FONT=&quot]epackager, although the accessories are sold as part of device X and also separately, the packages could be considered as shipping containers?[/FONT]

In gray area situations like this, it's appropriate to have a Memo to File that describes your analytical process in regard to each of the possibly applicable approaches, so that in the event of an inspection you can show how you arrived at what you're doing.
Agree, a letter to file seems to be a good solution especially if ABC decides not to list the accessories.


Regards,
AK
 
M

MIREGMGR

#5
As per definition of relabeler, since ABC does not change the content but just adds its name, it seems to be non-applicable.
What does "just adds its name" mean? This wasn't mentioned in your original post. Do you over-label some or all of LMN's original label?

the packages could be considered as shipping containers?
I don't know what this means, either. The original post didn't mention re-packaging. Do you just put your device and the accessories into a shipping box? Or, something else?
 
R

redknight07

#6
Apologies for the lack of clarity:

[FONT=&quot]As per definition of relabeler, since ABC does not change the content but just adds its name, it seems to be non-applicable.[/FONT]
[FONT=&quot]What does "just adds its name" mean? This wasn't mentioned in your original post. Do you over-label some or all of LMN's original label?[/FONT]
[FONT=&quot]We don’t modify the label in any way. Before sending the accessories over to us, LMN includes a label which states ABC as the distributor and a part number assigned as per ABCs system for those accessories/devices.[/FONT]
[FONT=&quot]_________________[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]the packages could be considered as shipping containers?[/FONT]
[FONT=&quot]
[/FONT]

[FONT=&quot]I don't know what this means, either. The original post didn't mention re-packaging. Do you just put your device and the accessories into a shipping box? Or, something else?[/FONT]


As per the definition of Repackager provided on http://www.fda.gov/MedicalDevices/D...istrationandListing/ucm053165.htm#definitions


[FONT=&quot]Repackager[/FONT] - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
[FONT=&quot]
The accessories are sold with the device as well as separately. When sold with a device, they are included in the device packag[/FONT][FONT=&quot]e which is discarded after installation. When sold separately, the box is just meant for shipping purposes.

AK[/FONT]
 
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