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.

An FDA webpage provides information