Hello Anon,
It depends on the region, depends on what is being over-labelled, if the over-label changes any perceived safety or performance of device, etc. Generally, I would say this is frowned upon by any regulatory agency though depends on if this is a distributor address label or if there are additional "functional" labels being added. In some cases, when say a distributor contact label is added, sometimes this is accepted, but the question is a bit too broad to answer specifically.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Jan-2021 13:02
From: Scott Bishop
Subject: Over labeling -Countries OUS
Dear Anon,
Thanks for reaching out -
To clarify, is your question whether over-labeling devices are allowed to move outside the US or whether they are allowed into? This may impact the final answer for some geographies.
Regardless - the broader questions to confirm are...why is it necessary and are there sufficient processes for identification and traceability in place?
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Scott Bishop
Houston TX
United States
Original Message:
Sent: 08-Jan-2021 11:10
From: Anonymous Member
Subject: Over labeling -Countries OUS
This message was posted by a user wishing to remain anonymous
Dear All,
Have ever you had experience with over-labeling for Medical Devices? is it allowed out of the US? (Sterile and non-steril Medical Devices)
thank you