The Cove Business Standards Discussion Forums
Address change on Medical Device labeling
Please read this thread...
Software update
Address change on Medical Device labeling
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Address change on Medical Device labeling

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
labeling requirements, medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 4th November 2010, 12:43 PM
Elroyfitz

 
 
Total Posts: 2
Please Help! Address change on Medical Device labeling

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!!

Sponsored Links
  Post Number #2  
Old 4th November 2010, 12:54 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,362
Re: Address change on Medical Device labeling

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.
Thank You to somashekar for your informative Post and/or Attachment!
  Post Number #3  
Old 16th November 2010, 03:43 AM
sreenu927

 
 
Total Posts: 541
Re: Address change on Medical Device labeling

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
Thanks to sreenu927 for your informative Post and/or Attachment!
  Post Number #4  
Old 16th November 2010, 11:36 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Address change on Medical Device labeling

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.

Quote:
...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.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #5  
Old 16th November 2010, 04:07 PM
Elroyfitz

 
 
Total Posts: 2
Re: Address change on Medical Device labeling

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!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Change of Medical Device Company Registered Address - Implications Sue789 Quality Manager and Management Related Issues 3 20th February 2015 01:31 PM
Class IIa Medical Device - Can I over label to change an address? J1980b ISO 13485:2016 - Medical Device Quality Management Systems 3 26th January 2012 04:42 AM
Regulations for Relabeling of Medical Device for Address Change drewsky1 ISO 13485:2016 - Medical Device Quality Management Systems 1 14th February 2011 06:27 PM
Address on Label - Medical Device Labeling Requirements Burgmeister 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7 22nd July 2010 03:00 AM
MDD Definition of Address as it applies to Medical Device Labeling LHAMROWCT EU Medical Device Regulations 20 3rd November 2009 11:47 PM



The time now is 05:31 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"