Re-packager/Re-Labeler - FDA Registration question

Z

znelson

My company is planning to register as a re-packager/re-labeler for a Class II cardiac monitor. My question is regarding how we should be registering our facility with FDA (we are already registered as a manufacturer).

Clearly we will need to register as a re-packager/re-labeler of the cardiac monitor [510(k)]. However, is it necessary to register the 510(k) of the disposable ECG electrodes that will be used with the monitor? We are not changing the immediate packaging or labeling of the ECG electrode pouches. We plan to remove the sealed pouches from the OEM ECG packaging and place the electrode pouches with the re-packaged/re-labeled cardiac monitor.

Does anyone have any experience with a situation like this? Thanks for your help.
 
M

MIREGMGR

It sounds to me as if you'll be a kit assembler, not a repackager.

You might additionally be a relabeler depending on whether you leave the existing labeling and perhaps add a supplemental label to identify yourself, or instead overlabel or otherwise entirely replace the existing labeling with your own labeling.

You aren't "changing your registration". There aren't different types of registration. What you'll be doing, rather, is declaring as you list each of your products, what your activity is in regard to that product. You'll check off each activity-category that applies.
 
S

Sheila1

Starting to get Involved
I had a question about relabelers and registration/listing. I understand that if you leave the original OEM label in place and add a sticker saying "Manufactured for" or "Distributed by" then you are not a relabeler. I also understand that if you completely replace the label or over-label and label the device in your own name, you are a relabeler (and possibly a manufacturer). However, do you become a relabeler and need to list the device if you over-label or replace the label and the new label has the "Manufactured for" or "Distributed by" designation (the original manufacturer is aware of this)? How would this be different from a private labeling scenario where the OEM does the labeling in the distributor's name?

Thanks!
 
Ronen E

Ronen E

Problem Solver
Moderator
Sheila1 said:
I had a question about relabelers and registration/listing. I understand that if you leave the original OEM label in place and add a sticker saying "Manufactured for" or "Distributed by" then you are not a relabeler. I also understand that if you completely replace the label or over-label and label the device in your own name, you are a relabeler (and possibly a manufacturer). However, do you become a relabeler and need to list the device if you over-label or replace the label and the new label has the "Manufactured for" or "Distributed by" designation (the original manufacturer is aware of this)? How would this be different from a private labeling scenario where the OEM does the labeling in the distributor's name?

Thanks!
Click to expand...

Hello Sheila and welcome to the Cove :bigwave:

You are in the grey area. To remove doubt, you better have a written contract with the OEM clearly stating that this is a private label arrangement and that they continue to bear all regulatory responsibility, ready to show to FDA investigators. To avoid complications I would also put in place a written agreement controlling the contents (and other properties) of the over-label and the way in which they can be changed through documented agreement between your company and the OEM.

In some specific circumstances you might get away with less (given some good will on FDA's part), but do you really want to take the risk?
 
Last edited:
shimonv

shimonv

Trusted Information Resource
Sheila1 said:
However, do you become a relabeler and need to list the device if you over-label or replace the label and the new label has the "Manufactured for" or "Distributed by" designation (the original manufacturer is aware of this)? How would this be different from a private labeling scenario where the OEM does the labeling in the distributor's name?
Click to expand...

Ronan, I liked what you wrote.
Sheila1, just to add form my understanding:
1. If you over-label than you are a relabeler.
2. If the manufacturer removes its own identification label and put the "Manufactured for" label with your information then its a private label scenario. The quality agreement between you and the manufacturer will determine who will bear the regulatory responsibility - you or the OEM.

So to answer your questions: For the fist question the answer is "yes". For the second question: Outwardly it looks like a private label, but if the manufacturer does all the work and assumes the regulatory responsibility than that puts you in a state of a distributor with no regulatory burden.

I hope it's clear & make sense.

-Shimon
 
S

Sheila1

Starting to get Involved
OK. That makes sense. If you do it yourself, you are a relabeler because you need quality controls to ensure the label is accurate. It was a bit unclear because of the "Manufactured for" indicating it is a distribution scenario.

Thanks!:thanx:
 
O

Oconster

I’ve read through here and I’ve got the understanding of where I think my company belongs, but here’s where I’m lost. We take a bulk pack device that is sold nonsterile and relabel it repackage it and sterilize it. We have a PLD agreement with the manufacturer and they know we do this. We import the device from Germany. The device was 510(k) approved for user sterilization (moist heat) and we are doing Gamma. What do we need to have in place to satisfy the fda? Thanks in advance.
 
P

paullarn

Registered
Hi Guys,
We have similar situation where a wrong UPC barcode was printed. Are we allowed to affix correct UPC barcode as repackager or relabeler?
 
C

cdmdux

Registered
paullarn said:
Hi Guys,
We have similar situation where a wrong UPC barcode was printed. Are we allowed to affix correct UPC barcode as repackager or relabeler?
Click to expand...

You would have to follow your quality agreement with the supplier first and foremost, but if it is a label you printed, you should be able to handle it through your standard nonconformance process and rework the product.

I would not modify or over-label the label of a supplier though, even if it is stated that you can in the quality agreement. With regards to enforcement action/recall responsibility, it would be the original manufacturer's responsibility to ensure the label is accurate and that they maintain retention labels, and it would be their responsibility to determine if the UPC issue is severe enough to warrant further action. Modifying the supplier's label would be a big issue - FDA could consider that adulteration of a product.
 
P

paullarn

Registered
cdmdux said:
You would have to follow your quality agreement with the supplier first and foremost, but if it is a label you printed, you should be able to handle it through your standard nonconformance process and rework the product.

I would not modify or over-label the label of a supplier though, even if it is stated that you can in the quality agreement. With regards to enforcement action/recall responsibility, it would be the original manufacturer's responsibility to ensure the label is accurate and that they maintain retention labels, and it would be their responsibility to determine if the UPC issue is severe enough to warrant further action. Modifying the supplier's label would be a big issue - FDA could consider that adulteration of a product.
Click to expand...

Hi ,
original UPC barcode Label was created by us. Due to different market channel requirement we have to modify UPC number and barcode. We are not planning to open sealed product. Just over labeling external UPC barcode. Do you see this as a problem?
 
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