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:
- Final Rule: Use of Symbols in Labeling
- Frequently Asked Questions
- FDA Voice: Using Symbols to Convey Information in Medical Device 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.