Product Labeling - Modified the name of one of our products

tiptoe

Starting to get Involved
#1
Hi Labeling experts,

We just recently modified the name of one of our products from X tissue gel to X topical gel. The name has been updated in our IFU, primary box packaging to reflect the modification however, the tube still bears the old name (X tissue gel). Is it acceptable on a regulatory stand point to have this or is it a requirement to have all names and labeling matching. Please advice. Thank you
 
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shimonv

Trusted Information Resource
#2
short answer: I recommend making this change effective from the time new tubes with the new name is available in stock. Otherwise you are looking at regulatory risk, and the higher the classification the more serious it becomes.

Shimon
 

tiptoe

Starting to get Involved
#3
short answer: I recommend making this change effective from the time new tubes with the new name is available in stock. Otherwise you are looking at regulatory risk, and the higher the classification the more serious it becomes.

Shimon
Would you be kind to elaborate more on some of the regulatory risk you speak of (Class IIa device), as I would like to make a case with my boss regarding that so they understand the implication and risk ahead. Also, are there any regulations and if so where can I find them to reference. Thank you
 

Edward Reesor

Trusted Information Resource
#4
From a risk mitigation standpoint, I believe that in the event of a recall or alert, having something labeled differently from what is in the IFU or box is not a desirable scenario. This might not be stated in FDA Labeling guidelines (21 CFR 801.1), but I believe it would be best practice and something you don't have to spend time on during your next audit. In ISO 14971, you have to remove the economical aspect of a risk mitigating decision and do what is best (not cheapest).

I also believe that you would avoid a whole lot of inquiries from customers doing it smoothly in one move. Will you have product returned when people see the difference? Do you have a plan for that? Are your distributors prepared to deal with these issues on your behalf? You do run the risk of an inspector denying the shipment based on "mislabeling", which may be defendable (you may be able to argue it successfully 10 times out of 10).

The question is, "Do you really want to have those arguments"? If it really worth your time?
 

dgrainger

Trusted Information Resource
#6
Essential requirements 13.3. b and 13.6.a require that the labelling has "details strictly necessary to identify the device and the contents of the packaging especially for the users".
Not sure if you can demonstrate this if the box & IFU state "X topical gel" but device is "X tissue gel".
You also have to give the product name in your Declaration of conformity.
 
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