Change in manufacturer address

eccaus

Starting to get Involved
This is probably a silly question.... but I am hoping that the community can help pointing me in the right direction....
We are the legal manufacturer of a few PMA products and 510(k) products, but we use contract manufacturers to perform the actual manufacturing, sterilization, etc.
Our address is on all the product labels and registrations, but we do not actually manufacture products - we receive finished devices, store them in our warehouse, and ship them to customers.
Our office is moving to a new address and we are wondering if we need to do anything other than updating our establishment listing in FURLS, and changing the address on our labels moving forward.
I have reviewed the manufacturing site change guidance and, since we do not perform any manufacturing activities at our site, it doesn't seem like a manufacturing site change supplement is required.
Am I understanding it correctly?
Thank you all in advance...!
 

EmiliaBedelia

Quite Involved in Discussions
Caveat that I am not super familiar with PMA requirements - if the actual site is not moving then I agree that the mfg. change probably doesn't apply, but you may need to document something for the labeling/IFU change.

For 510k products, you really just have to update the establishment registration and probably do a letter to file for the labeling change. It's much simpler than it feels like it should be, but it's true, there really isn't that much that is required.

However, note that a site move is probably going to be a pretty interesting change for your next inspection or MDSAP audit... so make sure that you complete all the procedure updates and verification or whatever you need to fully qualify your new site. It will make your life much easier if you document it well through a checklist/quality plan/whatever your change control document is called.
 
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eccaus

Starting to get Involved
Thank you very much for your reply, Emilia!
Those are all good recommendations. Yes, we are planning to document the labeling/IFU change in a future submission related to labeling changes for our PMA products, and a LTF that can also cover the 510(k) products. We have completed our MDSAP/ISO verification audit for the new site.
Thanks again! :)
 

petdressiva

Starting to get Involved
Hi, I apologize if Im hijacking your post, but I would like to ask:
We are currently changing our site in Canada and maybe just 6km from the original site, and our activity involves exporting to US. We have 510(k) approval to our products. If we updated our FURLS account to reflect the change of address/site and just create a LTF, does it cover our change with FDA regulations and we can continue our usual exporting activity or we should also consider Health Canada regulations?
 

eccaus

Starting to get Involved
Hi, I apologize if Im hijacking your post, but I would like to ask:
We are currently changing our site in Canada and maybe just 6km from the original site, and our activity involves exporting to US. We have 510(k) approval to our products. If we updated our FURLS account to reflect the change of address/site and just create a LTF, does it cover our change with FDA regulations and we can continue our usual exporting activity or we should also consider Health Canada regulations?
Hello, are there any manufacturing activities performed at your Canada site, or is it just a warehouse/office facility that ship out products to the US?
If there is no manufacturing involved, then based on what you described I believe you are covered on the US side.
As to Canada... If this product is also registered in Canada then you'd need to submit a minor change fax-back form to Health Canada (assuming there is no manufacturing facility change). If the product is for export only, then I believe you are covered on the Canada side.
 
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