Health Law Daily FDA aligns device labeling with foreign markets, allows stand-alone symbols
Wednesday, June 15, 2016

FDA aligns device labeling with foreign markets, allows stand-alone symbols

By Bryant Storm, J.D.

Graphical representations of information, or symbols, without adjacent explanatory text can be used in medical device and certain biological product labeling under a new FDA Final rule. While the use of symbols with adjacent explanatory text continues to be permitted, the Final rule authorizes the "stand-alone symbols" when they are established in a standard set by a standards development organization (SDO) and certain other requirements are met. The approval of stand-alone symbols is designed to make FDA labeling rules consistent with the current use of symbols on devices manufactured for European and other foreign markets. (Final Rule, 81 FR 38911, June 15, 2016).

Stand-alone symbols. Under previous FDA interpretations of labeling regulations, symbols were not permitted as part of medical device labeling, unless the device labeling included explanatory text or was on in vitro diagnostic devices. Under the Final rule, stand-alone symbols are permitted when they are established in a standard set by an SDO, part of a standard recognized by the FDA, and explained in a symbols glossary accompanying the medical device. The Final rule also allows the use of the symbol or statement "Rx only" for labeling of prescription devices.

Standards. The Final rule specifically requires that manufacturers use stand-alone symbols established by a standard that is recognized by the FDA—under section 514(c) of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 360d(c))—and used in accordance with an SDO’s specifications for use of the symbol set. Alternatively, manufacturers can use symbols with a standard not recognized by the FDA, if the device manufacturer otherwise determines that the symbol is used in accordance with the SDO’s specifications and is "likely to be read and understood by the ordinary individual under customary conditions of purchase and use." The new regulations define an SDO as "an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent."

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