Labeling Responsibility - Manufacturer vs. Repacker? Proper Component Use

[Gert Sorensen]

Is there an existing or new clause in the CFR which addresses the question of labeling for medical kits assembled from finished products made by other manufacturers, especially when the assembler is performing a sterilization process on the assembled kit? Specifically, I'm interested in what input the third party manufacturers could or should have on the labeling to assure proper use of the components they have manufactured which are in the kit

 

[Al Rosen]

Is there an existing or new clause in the CFR which addresses the question of labeling for medical kits assembled from finished products made by other manufacturers, especially when the assembler is performing a sterilization process on the assembled kit? Specifically, I'm interested in what input the third party manufacturers could or should have on the labeling to assure proper use of the components they have manufactured which are in the kit

Is this a kit for use by a physician or healhcare professional?

 

[Gert Sorensen]

Hi Al,

The kits are used by doctors during surgery. They can contain various items such as stents, catheters, guidewires, dilators, needles etc.

 

[Al Rosen]

Hi Al,

The kits are used by doctors during surgery. They can contain various items such as stents, catheters, guidewires, dilators, needles etc.

If they are prescription devices, you should read Guidance for Industry and FDA on Alternative to Certain Prescription Device Labeling Requirements.

I don't think the issue is what regulations exist, but what agreement you have with your customer. You can look at all the guidance from the FDA, but I believe there is nothing other than the information I posted here.

You can find all the labeling guidance on the FDA Labeling Requirements web page.

I hope that someone else can add some more to this if there is something that I might have missed or that I'm not aware of.

 

[wrodnigg]

I can just give you an european view:

It depends, if the parts of the kit are "adulterated" according to their primary intended use.

If the products are used as intended in the original product, no further labeling is needed, the original labeling must not be removed or changed.

If the intended use of at least one part of the kit differs from the original one, the whole kit is a new product and the repacker becomes a manufacturer.

The concept of "finished device" does not imply that a device when
reaching the final user is already in a state ready for use. Prior to use
further preparatory processing, preparation, configuration,
installation, assembling, adaptation or fitting to the needs of the user
or patient may be required. Examples :
- sterilisation of medical devices supplied non-sterile
- assembling of systems
- configuration of electronic equipment
- preparation of a dental filling
- fitting of contact lenses
- adaptation of prosthesis to the needs of the patient.
The aforementioned activities are normally not manufacturers
activities if they are carried out by the final user as part of the use or
preparation for use. In this context a distinction needs to be made
between a typical professional activity performed by a healthcare
professional and processing and assembling activities done by a
specialist for such processing. In the latter case relevant activities may
become proper manufacturing or assembling activities relevant within
the meaning of articles 11 and 12 MDD.

~ghw

 

[ontheopenroad]

Are these custom kits or are they standard inventory items for your company? That may make a difference. I used to work for a custom tray division of a medical device manufacturer, and the way we handled depended on whether they were custom or stock.

Are you buying bulk components (the stents, etc.), or are they in an original manufacturer's package inside your package?

Do you get/have instructions for use from the OEM?

 

[Wes Bucey]

Are these custom kits or are they standard inventory items for your company? That may make a difference. I used to work for a custom tray division of a medical device manufacturer, and the way we handled depended on whether they were custom or stock.

Are you buying bulk components (the stents, etc.), or are they in an original manufacturer's package inside your package?

Do you get/have instructions for use from the OEM?

You may have missed the main theme here. The original poster is an OEM making medical devices. An affiliated kit maker is buying his components to assemble into kits for sale. He wrote about it in http://elsmar.com/Forums/showthread.php?t=17302
It appears Gert wants to make sure he and his company :ca: on labeling. It's still not clear whether ONLY Gert's products are in the kit or whether there are products from other manufacturers included in the kits.

It would seem a pretty straightforward resolution if ONLY Gert's products are included in the kit. Things get dicey when other manufacturers are involved (could there be some incompatibility between the products from different manufacturers?)

How about some more info, Gert?

 

[Gert Sorensen]

You may have missed the main theme here. The original poster is an OEM making medical devices. An affiliated kit maker is buying his components to assemble into kits for sale. He wrote about it in http://elsmar.com/Forums/showthread.php?t=17302
It appears Gert wants to make sure he and his company :ca: on labeling. It's still not clear whether ONLY Gert's products are in the kit or whether there are products from other manufacturers included in the kits.

It would seem a pretty straightforward resolution if ONLY Gert's products are included in the kit. Things get dicey when other manufacturers are involved (could there be some incompatibility between the products from different manufacturers?)

How about some more info, Gert?

More info, certainly.... We deliver only part of the kits, the repacker may also supply items as well as buy items from other sources. That's the tricky part of it. The repacker have been assembling these kits for years, and we have not received any information that there is any problem regarding neither our product nor the kit itself.
So, where does our responsibility for the use of our item stop?