U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Overview of Device Regulation
  5. Device Labeling
  6. Use of Symbols in Labeling
  1. Overview of Device Regulation

Use of Symbols in Labeling

Use of Symbols in Labeling

The Food and Drug Administration (FDA) issued a final rule, Use of Symbols in Labeling, June 15, 2016, that became effective September 13, 2016. The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text (referred to as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements.

Below is a list of resources on the use of symbols in labeling:

If you have questions about implementing the Symbols final rule, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by phone at 1-800-638-2041, or 301-796-7100.