FDA Allows Some Symbols on Medical Device, Biologics Labels

The Food and Drug Administration on June 15 issued a final rule (here) allowing use of symbols on labeling for medical devices and biological products. The symbol must have been established as part of a standard developed by a nationally or internationally recognized standards development organization and used according to that standard. Alternatively, symbols not recognized or not used in accordance with the standard may still be used if the meaning is likely to be clearly understood by the public. Either way, the symbol must be explained in a symbols glossary that accompanies the device, the agency said. FDA is also proposing to allow the statement “Rx only” on the labeling of prescription devices. The new regulations take effect Sept. 13.