The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory text if certain requirements are met. This rule is intended to better conform U.S. labeling requirements for symbols with regulatory requirements in European and other foreign markets.
The final rule allows symbols established in a standard developed by a standards development organization to be used in medical device labeling without adjacent explanatory text if (1) the standard is recognized by the FDA and the symbol is used in accordance with certain specifications for use set forth in the Food and Drug Modernization Act of 1997 or (2) the device manufacturer otherwise determines the symbol is likely to be read and understood by an ordinary individual under customary conditions of purchase and use in compliance with certain misbranding stipulations under the Federal Food, Drug, and Cosmetic Act and the manufacturer uses the symbols according to specifications for use set forth in the standards development organization’s developed standard.
Examples of international consensus standard symbols can be found in “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use,” an FDA Guidance Document issued on November 30, 2004, that recognized 25 symbols from two international consensus standards for IVD devices for professional use. Symbols from that Guidance Document are reproduced below:
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This final rule is estimated to lead to cost savings between about $7.9 million and $25.5 million for medical device manufacturers and will go into effect on September 13, 2016.