Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

We are planning to change our carton artwork to remove a few symbols (among other things) that are not needed. These symbols are defined in a symbols glossary in the associated IFU. My question is, does the IFU need to be updated immediately to remove the symbols and implemented at the same time as the new carton or can I use up the current inventory of IFUs with the new carton and switch to an updated IFU (w/o those symbols) when the current IFUs (w/symbols) are depleted from inventory? 

Thanks!

Best to update the IFU at the same time with the changes to carton artwork.  That way they are consistent and not out of line.  Best way to keep track of things and best for regulatory submissions.  Really hard to track when marking and labeling out of synch and reporting gets even more complex.  I would highly recommend to avoid being "out of synch".  Will cause quite a problem and you will end up having many problems that are not worth it.

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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
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Original Message:
Sent: 13-Jan-2022 09:20
From: Anonymous Member
Subject: Symbols in IFU Glossary but not on product labeling

This message was posted by a user wishing to remain anonymous

Hello All,

We are planning to change our carton artwork to remove a few symbols (among other things) that are not needed. These symbols are defined in a symbols glossary in the associated IFU. My question is, does the IFU need to be updated immediately to remove the symbols and implemented at the same time as the new carton or can I use up the current inventory of IFUs with the new carton and switch to an updated IFU (w/o those symbols) when the current IFUs (w/symbols) are depleted from inventory?

Thanks!

If you are simply removing symbols from the carton you should be fine to use your existing IFU inventory. This assumes you do not have any reproductions of the full carton labeling which could cause confusion. Many manufacturers have a glossary of symbols with definitions at the back of their IFU which contain symbols not present in the specific labeling (IFU, device labels, etc.) which allows them to use the same table from device to device.

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Wade Munsch
Regulatory Affairs Manager, Biotex, Inc.
Houston TX
United States
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Original Message:
Sent: 13-Jan-2022 09:20
From: Anonymous Member
Subject: Symbols in IFU Glossary but not on product labeling

This message was posted by a user wishing to remain anonymous

Hello All,

We are planning to change our carton artwork to remove a few symbols (among other things) that are not needed. These symbols are defined in a symbols glossary in the associated IFU. My question is, does the IFU need to be updated immediately to remove the symbols and implemented at the same time as the new carton or can I use up the current inventory of IFUs with the new carton and switch to an updated IFU (w/o those symbols) when the current IFUs (w/symbols) are depleted from inventory?

Thanks!