FDA Allows Stand-Alone Symbols In Device Labels, With Symbol Glossary

FDA recently released a final rule allowing device manufacturers to use stand-alone symbols in labeling in a move toward harmonization with foreign regulatory schemes that have allowed symbols alone for years. Prior to finalization of the rule, which the agency proposed three years ago, U.S. manufacturers were required to include explanatory text next to the symbol, which one industry attorney noted defeated the purpose of using a symbol. “The Food and Drug Administration (FDA or the Agency) is issuing this...