The final rule, in addition to allowing the optional use of symbols not accompanied by explanatory text (“stand-alone symbols”), permits the use of the symbol statements “Rx only” and “℞ only” for prescription devices, provided they meet the rule’s requirements.
Previously, the FDA prohibited companies from using stand-alone symbols on device and IVD labels and required that symbols on the labels be accompanied by explanatory text. Requests from the medical device industry led the agency to seek public comment in 2013 on a proposed rule that would allow stand-alone symbols to appear on device labels. In its final rule, titled “Use of Symbols in Labeling,” the agency didn’t bend on its requirement that all stand-alone symbols must be explained in a paper or electronic glossary included with the device – despite industry pressure for it to do so. Furthermore, the rule stipulates that the labeling on or within the device’s packaging must include a prominent and conspicuous statement identifying the location of the glossary.
However, the final rule does differ from the proposed rule on one major front: It now allows manufacturers to include stand-alone symbols not recognized by the FDA, in addition to those developed by recognized standards development organizations. In those cases, companies can use their discretion as long as they determine a symbol is likely to be read and understood by an ordinary individual under customary conditions of purchase and use, in compliance with the Food, Drug and Cosmetic Act. The FDA also notes it still has authority to determine whether a symbol is noncompliant with the rule and to take enforcement action against violations.
The final rule will go into effect Sept. 13, 2016.