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We recently submitted a 510k to the FDA for a ob/gyn cell collector. The product is single use and will only be utilized by doctors in a professional setting (will not be available to the public).
We followed the FDA "Guiance for Insustry and FDA Staff-Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use". We included the symbol on the label with a "2" with a circle and slash through it to distringuish this item as a single use item, as well as an hour glass for expiration date, and a symbols for see instructions for use.
We received a letter from the FDA with some concerns about the labeling which state "device labels include non-recognized symbols for single use only, see instructions for use, and expiration date. Please replace these symbols with text".
The request may seem simple to replace with text but our labels have mutiple languages and are relatively small and we want to keep everything clear. We do plan on complying with the FDA request.
We reviewed other devices that our similar to ours that used the same symbols. We thought that FDA document would be applicable to our device but now we are wondering why the FDA would say the symbols are non-recognized. Any insight would be helpful.
We followed the FDA "Guiance for Insustry and FDA Staff-Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use". We included the symbol on the label with a "2" with a circle and slash through it to distringuish this item as a single use item, as well as an hour glass for expiration date, and a symbols for see instructions for use.
We received a letter from the FDA with some concerns about the labeling which state "device labels include non-recognized symbols for single use only, see instructions for use, and expiration date. Please replace these symbols with text".
The request may seem simple to replace with text but our labels have mutiple languages and are relatively small and we want to keep everything clear. We do plan on complying with the FDA request.
We reviewed other devices that our similar to ours that used the same symbols. We thought that FDA document would be applicable to our device but now we are wondering why the FDA would say the symbols are non-recognized. Any insight would be helpful.
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