Hi Allyson
Do you have a " see instructions for use " symbol on the label?
For certain then you can explain your symbols in the IFU, and and as you stated EU does not recognize it anyway and it will need explanation in the IFU.
There are many harmonized symbols EU does not recognize without explanation. And recent Human Factor publications still show medical professionals only understand 6-7'symbols, including the sterile symbol, lot #, etc.
Best most likely to have a symbol explanation table in the IFU, with the source of the symbol identified, as FDA likes. Will satisfy FDA, EU and healthcare professionals (if they bother.to read it).
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 23-Jul-2019 09:58
From: Allyson Swartz
Subject: Negation of Latex Symbol following ISO 15223-1:2016
We are working to address the Dec 2014 FDA guidance regarding "not made with natural rubber latex" instead of saying "latex-free". We have been looking for a symbol to use to indicate "not made with natural rubber latex" rather than putting that text directly on the labels (and potentially needing to translate on the label). Does the FDA accept the "negation" of the latex symbol following item 5.4.5 and Annex B point B.2 of ISO 15223-1? Can anyone confirm if the FDA has accepted this approach or if they have had issues with this? I know they recognize ISO 15223-1 but Annex B point B.2 references an IEC standard for how to negate symbols and it doesn't appear they recognize that IEC standard.
Thank you,
Ally Swartz
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Allyson Swartz
Quality Engineer II
Coralville IA
United States
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