Hello Alexandra
If I'm understanding the question, then yes, it is a challenge... I'd say the main thing is your labels should make sense to your users. And you may need to provide some additional information in the accompanying documentation.
Operationally, it might be easiest to label the screws as just "Screw Model 1", assuming that your users don't have a significant risk of mixing up the wrong screw models with the wrong product families.
If there is such a risk, or if you want to give your users more confidence, you may choose a more complicated manufacturing and labeling system, where some of the same screws are labeled "Screw Model 1 for the Symphony 100" and others as "Screw Model 1 for the Symphony 200".
As Richard says, manufacturers have a lot of options.
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Anne LeBlanc
United States
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Original Message:
Sent: 13-May-2022 03:48
From: Richard Vincins
Subject: Labels - Trade System Name requirement
Alexandra,
Your welcome, maybe ... because I am still not following sorry. Might have to see some graphical or pictorial view of this to really understand because I can kind of see how you are using components across multiple families. Though I know due to proprietary or confidential this might not be possible on an open forum. I am still not getting the relation to the Trade Name of the system as compared to models. I think from my perspective there is a requirement for identification of product on a label, but how this is done is completely up to the manufacturer. I realise to that space on labelling can be quite challenging. You could probably think of some creative ways to complete this maybe using coding or references which the end user could easily discern.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 12-May-2022 16:21
From: Alexandra Rodriguez
Subject: Labels - Trade System Name requirement
Hello Richard,
Thanks for replying to my post. What I mean is that in the case of orthopedics there are product families that share or use the same models (e,g screw model 1 can be used and has been cleared to be used in Family 1, Family 2, Family 3 etc..). For the Trade System name requirement this specific case is challenging because we would have to name all the multiple families the model is associated with in the label.
Best,
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Alexandra Rodriguez
Miami FL
United States
Original Message:
Sent: 11-May-2022 08:09
From: Richard Vincins
Subject: Labels - Trade System Name requirement
Hello Alexandra,
Sorry, I am not following your question and how it would relate to being used across multiple systems. Typically a product family with different models or variants would have a Trade Name - such as "Symphony" with model numbers 100, 200, and 300. Each of the models might be a bit more specific like Model 100: Symphony Heavy, Model 200: Symphony Medium, or Model 300: Symphony Light. Maybe the other option could look at is the product name just uses a Generic Name for the product type, like Perfusion System, and then use further descriptive information in the labelling.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 10-May-2022 11:51
From: Alexandra Rodriguez
Subject: Labels - Trade System Name requirement
Hello everyone,
I would like to know based on your experience how have you addressed the FDA requirement for the trade system name in the medical device labels for those devices that are used across multiple systems (e,g a device used across 7 different systems) . I'm having some space issues with the labels and this requirement. I appreciate your feedback !
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Alexandra Rodriguez
Miami FL
United States
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