Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Our IVD Test has a Trademarked named, therefore on our labeling we use is XXXX^TM. In preparing the final PMA submission to the FDA, do I need to use the ^TM throughout the PMA with each mention the device name? FDA does not give any guidance to common writing addressing this. I know in common business writing you use the symbol in the first sentence and then the remaining instances without. But I'm not sure if this is the same for FDA submissions, especially PMA's which can be lengthly.

Hello Anon,

Personally I do the same is first instance and any "official" place where the Trade Name is stated include the trademark symbol.  Keep in mind the trademark symbol also may only be applicable to certain regions.  In honesty, a reviewer does not really worry if there is a trademark symbol there or not as this does not have bearing on the regulatory aspect.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Jul-2022 10:10
From: Anonymous Member
Subject: Trademark Symbol in Device Name

This message was posted by a user wishing to remain anonymous

Hello,

Our IVD Test has a Trademarked named, therefore on our labeling we use is XXXX^TM. In preparing the final PMA submission to the FDA, do I need to use the ^TM throughout the PMA with each mention the device name? FDA does not give any guidance to common writing addressing this. I know in common business writing you use the symbol in the first sentence and then the remaining instances without. But I'm not sure if this is the same for FDA submissions, especially PMA's which can be lengthly.

Original Message:
Sent: 7/25/2022 10:11:00 AM
From: Anonymous Member
Subject: Trademark Symbol in Device Name

This message was posted by a user wishing to remain anonymous

Hello,

Our IVD Test has a Trademarked named, therefore on our labeling we use is XXXX^TM. In preparing the final PMA submission to the FDA, do I need to use the ^TM throughout the PMA with each mention the device name? FDA does not give any guidance to common writing addressing this. I know in common business writing you use the symbol in the first sentence and then the remaining instances without. But I'm not sure if this is the same for FDA submissions, especially PMA's which can be lengthly.