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Stand-Alone Symbols Allowed on Medical Device Labeling Under FDA Proposal

Friday, April 19, 2013
By Shawn McCausland
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is proposing to revise its medical device and biological product labeling regulations to explicitly allow the inclusion of stand-alone symbols. The FDA notes that this change would harmonize differing U.S. and European Union regulatory requirements that have forced manufacturers to develop different labels for each market. The FDA is also proposing to revise 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. Comments on this proposed rule are due no later than June 18.

Under current FDA regulations, graphics, pictures or symbols in medical device labeling that represent required information must be accompanied by explanatory English text adjacent to the symbol. The FDA is now proposing to expressly allow (but not require) the use in such labeling without adjacent explanatory text of symbols contained in a standard that the FDA recognizes under its authority under section 514(c) of the Federal Food, Drug and Cosmetic Act. Devices on which such symbols are used would have to be contemporaneously accompanied by a “symbols glossary” that lists each symbol used in the labeling of the device as well as the meaning or explanatory text for the symbol.

The FDA states that it will generally consider recognizing symbols included in standards if it determines that the device user, under customary conditions of purchase and use, will understand the meaning of the symbol and the message it is intended to convey. The FDA expects to assess standardized symbols from time to time and will maintain an up-to-date list of recognized symbols on its Web site.

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