Allyson,
On the direct device label we have had the symbol accepted because under the FDA's symbol reulgation, they accept symbols from a recognised standard which ISO 15223 is recognised. We have seem them accept the "negation" of a symbol too though it might be reviewer dependent. Just make sure to include the symbol glossary in the IFU. Also we put the FDA's "latex statement" as note in the beginning of the IFU as well - just so we had the wording included somewhere. This is particularly important when there are medical devices which may not be clear if they have latex materials or not.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Jul-2019 09:59
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.
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Allyson Swartz
Quality Engineer II
Coralville IA
United States
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