Address change on Medical Device labeling

#1
Hello everyone,

I work for a medical device company that manufactures knee implants and only distributes product in the U.S. (currently not CE marked). We have consigned inventory at a few sites and inventory that we store in house. Our company is moving to a new location (same city, different address and zip) our labeling needs to be updated to reference the new address. We will be updating our registration with the FDA, but I am having trouble finding any regulations or guidelines that cover the requirements for implementing a change to the address on existing labeled product. I have the following questions:

1. Do all labels (shelf box, tray, patient labels and IFU) need to be relabeled with the new address? If so, is there an allotted time frame for implementation? Or does all labeling need to be in place the exact day that the move takes place?

2. A couple instruments contain our address, do these items follow the same rules? (i.e. instrument tray, Controller)

3. What labeling types require the address of the manufacturer?

We currently have our address on everything (i.e. shelf box label, tray label, patient label, IFU, Surgical Technique, instrument tray, etc.). When updating all labeling for this change I am going to remove it from anything that is not required to have it. To prevent this from reoccurring in the future. Any help with this would be GREATLY APPRECIATED!

Thanks in advance!!
 
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somashekar

Staff member
Super Moderator
#2
Welcome to the Cove.
This is a good case for implementing Advisory notice as a means of effective arrangements for communicating with customers in relation to your change of address.
You may do nothing with the already labeled products that are in the pipeline of distribution. From the determined date of location change, your label with the new address can be used and all labels with old address gathered and distroyed.
 

sreenu927

Quite Involved in Discussions
#3
Hi,
Further to Somashekar's suggestion, I wud like to add the following:

When your facility(!!) is changing, make sure your quality management system is updated with your certification body (for ISO 13485).

for address change, make sure that this won't affect the performance of the product and file a letter-to-memo as a justification for not notifying to FDA and file it in the DHF. Take reference of 510(k) decision tree guidance doc for this.

1. Do all labels (shelf box, tray, patient labels and IFU) need to be relabeled with the new address? If so, is there an allotted time frame for implementation? Or does all labeling need to be in place the exact day that the move takes place?
Yes. From regulatory perspective no time frame, aslong as you move to the new location, and the products supplied has to be with new address. so make alignment of your plan.

2. A couple instruments contain our address, do these items follow the same rules? (i.e. instrument tray, Controller)
Yes.
3. What labeling types require the address of the manufacturer?
Primary and Secondary labels, and User documentation (IFU, user manuals,etc..).

Hope this helps!

Regards,
Sreenu
 
M

MIREGMGR

#4
The legal purpose of sufficient-address inclusion on labeling is so that end users of your devices can contact you by mail. It's easy and appropriate to arrange with the US Postal Service to forward mail to your new address, and this action can be noted in your memo to file as justifying no changes to product in the field or the distribution pipeline.

...file a letter-to-memo as a justification for not notifying to FDA and file it in the DHF.
Note however that you must immediately update your US FDA DRLM website information, i.e. the address for your Establishment registration.
 
#5
Thanks so much, this information helps a lot! We plan on writing a Quality Plan for the move which will document and justify all decisions made in regards to what product will be relabeled with the time frame for implementation. I am looking into how long the US Postal office forwards incoming mail to address locations and that will also be apart of the justification.

THANKS!
 
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