Medical Device Label Symbols
Medical devices symbols to be used with medical device labels labelling and information to be supplied part 1. It also lists symbols that satisfy the.
The food and drug administration fda or the agency is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information or symbols in labeling including labels.
Medical device label symbols. Iso 15223 12012 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. Product label symbols symbol. Iso 15223 1 medical devices symbols to be used with medical device labels labeling and information to be supplied 511 manufacturer indicates the medical device manufacturer as defined in eu directives 90385eec 9342eec and 9879ec.
Device labeling requirements for symbols with international requirements. It also lists symbols that satisfy the requirements of iso 15223 12012. The international standard symbols selected to be used with medical device labels are listed in iso 15223 12016 medical devices symbols to be used with medical device labels labelling and information to be supplied part 1.
In june of 2016 the fda issued a final rule use of symbols in labeling which allows for the use of symbols in all medical device labeling without additional explanatory textthe move was made in an effort to align the us. The final rule permits the use of symbols in all. Iso 15223 12016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
The use of symbols in medical device labeling final rule final rule including the requirement for a glossary only applies to symbols that are used to convey information required by or under. Iso 15223 12012 is applicable to symbols used in a broad spectrum of medical devices which are marketed. The food and drug administration fda issued a final rule use of symbols in labeling june 15 2016 that became effective september 13 2016.
This document includes visual examples of the symbols themselves along with their.
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