30 June 2016
FDA to Allow Stand-Alone Symbols on Medical Device Labelling
The Food and Drug Administration has amended the labelling regulations for medical devices and certain biological products to explicitly allow for the optional inclusion of graphical representations of information or symbols in labelling (including labels) without adjacent explanatory text if certain requirements are met, effective 13 September. The final rule also specifies that the use of symbols accompanied by adjacent explanatory text continues to be permitted. The agency has also revised its prescription device labelling regulations to allow the use of the symbol statement “Rx only” or “‘℞ only” in the labelling for prescription devices.
The FDA has generally interpreted existing regulations as not allowing the use of symbols in medical device labelling, except with adjacent English-language explanatory text and/or on in vitro diagnostic devices intended for professional use. However, under the final rule symbols established in a standard developed by a standards development organisation may be used in medical device labelling without adjacent explanatory text as long as:
- the standard is recognised by the 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 the FDA section 514(c) recognition; or
- if the symbol is not included in a standard recognised by the FDA under section 514(c) or the symbol is in a standard recognised by the FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, 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 compliance with section 502(c) of the FD&C Act and uses the symbol according to the specifications set forth in the relevant standard.
In either case, the symbol must be explained in a paper or electronic symbols glossary that is included in the labelling for the medical device. Moreover, the labelling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English (another language may be used if the article is distributed solely in Puerto Rico or in a territory where the predominant language is not English). As with text used in device labelling, the use of symbols must also comply with other applicable labelling requirements in the FD&C Act, such as section 502(a) and section 502(f), as well as relevant regulations such as 21 CFR part 801.