Use of Symbols in Labeling
Information
Type
Rule
Regulated products
Medical Devices
Published
June 15, 2016
Last updated
June 15, 2016
Description
Document number 2016-13989. The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document 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. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement "Rx only" or "[rx] only" in the labeling for prescription devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)