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  Use of Symbols in Device Labeling

On June 15, 2016 FDA issued a final rule Use of Symbols in Labeling. The rule is effective from September 13, 2016. The rule allows symbols in medical device labeling without adjacent explanatory text, i.e., “stand-alone symbols” when:

·         A national or international standards development organization (SDO) developed the symbol

·         A standard authorizes the “standardized symbol” for stand-alone use

·         The manufacturer includes a symbols glossary in the labeling for the device

 

To support the rule, FDA published a new standards-recognition notice to modify the current list of recognized standards.

 

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-13990.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

An FDA webpage provides information https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ucm555598.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

 
 
 
 
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