The Food and Drug Administration (FDA) has proposed revising medical device and biological product labeling regulations “to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization.” Under the proposed rules, manufacturers could use these standardized symbols provided they are “recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices” and “explained in a symbols glossary that contemporaneously accompanies the medical device.” The revised regulations would also authorize “the use of the symbol statements ‘Rx only’ on the labeling of prescription devices.”

According to its April 19, 2013, Federal Register notice, FDA ultimately seeks “to harmonize U.S. regulatory requirements with those of the European Commission” in the belief that “certain symbols contained in national or international standards are ‘likely to be read and understood by the ordinary individual under customary conditions of purchase and use.’” Once it finalizes these regulations, FDA plans on posting up-to-date information on its Website about the stand-alone symbols permitted for use in medical device labeling. In particular, FDA has pointed to international symbols standards developed by the Association for the Advancement of Medical Instrumentation as among those that are currently recognized by U.S. regulators. FDA will accept comments on the proposed rule until June 18.