Regulatory Open Forum

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Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States
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Hello Andrea, 

thanks for your reply. 

For the US it is perfectly clear and the product has a unique name here. 

The rest of the world shall be aligned. Marketing now wants to create general brochures and presentations only using the 'new' name. All direct product labeling like inserts, IFU, ... are of course using the correct, respective registered name. 

I am wondering, if I have to tell marketing that they need to align the brochures and presentations with each countries naming or if for material like that the construct using the 'NOTE:..' would be a workaround.

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Christine Teich
Langenlebarn
Austria

Original Message:
Sent: 16-Feb-2022 11:37
From: Andrea Chamblee
Subject: Different product names (medical device) worldwide - use in marketing material

Ooofff. Something they should have thought of in the beginning. That's why consultants that help chose names before international launch charge a fortune.  how-to-name-a-product

While you might be able to label a product with "NOTE: Due to country specific registrations, the XXX may be marketed under the following name in ANOTHER country: XXX," the US and many countries require the product name be the most prominent and conspicuous thing on the label. (The generic name may have to be second.) Your US approval (and perhaps your foreign approval) will also have labeling expectations. For example, your PMA labeling may be specific that doesn't anticipate multiple names, or a more prominent name. Even your 510(k) name on the label may raise issues; for example, if it alludes to a new intended use, it may make your product no longer substantially equivalent. Adding different names means you may not - or if you have limited room, cannot - be compliant in your country.

I am not experienced on international labeling, but perhaps we all have seen multi-lingual package inserts. Perhaps you could include those with a consistent name. Inserts are labeling, of course, but it may provide a reason to use a single name there.

FDA's CDRH has conveniently put all device labeling requirements on one page here: Device Labeling.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States
------------------------------

Hello Andrea, 

thanks for your reply. 

For the US it is perfectly clear and the product has a unique name here. 

The rest of the world shall be aligned. Marketing now wants to create general brochures and presentations only using the 'new' name. All direct product labeling like inserts, IFU, ... are of course using the correct, respective registered name. 

I am wondering, if I have to tell marketing that they need to align the brochures and presentations with each countries naming or if for material like that the construct using the 'NOTE:..' would be a workaround.

------------------------------
Christine Teich
Langenlebarn
Austria

Original Message:
Sent: 16-Feb-2022 11:37
From: Andrea Chamblee
Subject: Different product names (medical device) worldwide - use in marketing material

Ooofff. Something they should have thought of in the beginning. That's why consultants that help chose names before international launch charge a fortune.  how-to-name-a-product

While you might be able to label a product with "NOTE: Due to country specific registrations, the XXX may be marketed under the following name in ANOTHER country: XXX," the US and many countries require the product name be the most prominent and conspicuous thing on the label. (The generic name may have to be second.) Your US approval (and perhaps your foreign approval) will also have labeling expectations. For example, your PMA labeling may be specific that doesn't anticipate multiple names, or a more prominent name. Even your 510(k) name on the label may raise issues; for example, if it alludes to a new intended use, it may make your product no longer substantially equivalent. Adding different names means you may not - or if you have limited room, cannot - be compliant in your country.

I am not experienced on international labeling, but perhaps we all have seen multi-lingual package inserts. Perhaps you could include those with a consistent name. Inserts are labeling, of course, but it may provide a reason to use a single name there.

FDA's CDRH has conveniently put all device labeling requirements on one page here: Device Labeling.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States
------------------------------

Hello,

I am currently having a discussion with marketing. We have a medical device which has, depending on the registration in the respective country, different trade names. Now they want to align that naming to one name worldwide.

My questions is - as long as we have not re-registered the name everywhere - is it possible to use marketing material which is stating the anticipated new name and then add to each material something like:

NOTE: Due to country specific registrations, the XXX may be marketed under the following name in your country: XXX.

I am looking forward to your thoughts!

Thanks

Hello,

I am currently having a discussion with marketing. We have a medical device which has, depending on the registration in the respective country, different trade names. Now they want to align that naming to one name worldwide.

My questions is - as long as we have not re-registered the name everywhere - is it possible to use marketing material which is stating the anticipated new name and then add to each material something like:

NOTE: Due to country specific registrations, the XXX may be marketed under the following name in your country: XXX.

I am looking forward to your thoughts!

Thanks