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Stand-Alone Symbols Allowed on Medical Device Labeling

Wednesday, June 15, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule that, effective Sept. 13, will revise its medical device and biological product labeling regulations to explicitly allow the inclusion of stand-alone symbols. The FDA is also revising its prescription medical device labeling regulations to authorize the use of the symbol statement “Rx only” without accompanying explanatory text on the labeling of prescription devices.

FDA states that under this final rule, symbols established in a standard developed by a standards development organization may be used in medical device labeling without adjacent explanatory text as long as either (1) the standard is recognized by FDA under its authority under section 514(c) of the Federal Food, Drug and Cosmetic Act and the symbol is used according to the specifications set forth in that recognition, or (2) the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In either case the symbol must be explained in a paper or electronic symbols glossary whose location is prominently and conspicuously identified on the labeling on or within the package containing the device.

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