E
Elroyfitz
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!!
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!!