In the June 15, 2016, Federal Register, FDA issued a final rule revising the Agency's medical device and certain biological product labeling regulations. The final rule allows labeling to use stand-alone symbols (i.e., graphical representations of information, or symbols, without adjacent explanatory text) if certain requirements are met. In addition, the final rule revises FDA's prescription device labeling regulations to allow the use of the symbol statement "Rx only" in the labeling for prescription devices. The rule is effective September 13, 2016.
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