FDA Issues Final Rule Permitting Use of Symbols on Device Labeling

By Allyson B. Mullen –

Symbols have been an accepted part of device labeling outside of the U.S. for many years. In the U.S., however, symbols alone have not been permitted on medical device labeling, with the exception of guidance allowing use of “Rx Only.”  To have a single global label, device manufacturers have had to cram explanatory text next to symbols on labels and include lengthy lists of symbols in instructions for use manuals defining each symbol.  To add to the challenges, the explanatory text next to each symbol must be translated into numerous different languages to meet the legal and regulatory requirements of countries outside the U.S.  Obviously, all of this additional text defeats the purpose of using symbols, but is necessary for marketing in other countries, if companies want to have a single global product (i.e., a product with labeling that meets U.S. and OUS requirements).

Three years ago, FDA proposed a rule that would permit device manufacturers to use stand‑alone symbols on device labeling. In the meantime, this issue has continued to fester.  So it is good news that FDA finalized the rule on June 15, 2016. 

Under the final rule, device manufacturers may use symbols on device labeling in one of the following ways:

1. Continue using a symbol(s) with adjacent explanatory text.
2. Use a symbol alone without adjacent explanatory text, so long as any one of the following conditions are met:
1. (i) the symbol is taken from an FDA-recognized standard, (ii) it is used in accordance with the standard, and (iii) the symbol and its definition are included in a Symbol Glossary that is included with the device’s labeling.
2. (i) the symbol is taken from a standard developed by a standards development organization (SDO), but it is not FDA-recognized, (ii) it is used in accordance with the standard, (iii) the manufacturer makes a determination that “the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use,” and (iv) the symbol and its definition are included in a Symbol Glossary that is included with the device’s labeling.
3. (i) the symbol is taken from an FDA-recognized standard, (ii) it is NOT used in accordance with the standard, (iii) the manufacturer makes a determination that “the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use,” and (iv) the symbol and its definition are included in a Symbol Glossary that is included with the device’s labeling.

In scenarios 2.b and 2.c, the burden is on the manufacturer to determine that “the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” Validation of a device’s labeling may provide some evidence that the symbol is likely to be read and understood.  The final rule also now formally allows device manufacturers to use the Rx Only symbol in lieu of the longer prescription use only statement. 

The final rule is relatively unchanged from the proposed rule, which we previously blogged on here. The most significant changes from the proposed to the final rule are:

• Manufacturers may use symbols from non-FDA recognized standards without explanatory text, as long the requirements described above are met.
• The symbols glossary must be “included in the labeling” meaning either including a fully copy of the glossary in the paper labeling or a statement identifying the location of the glossary (e.g., a website link).
• FDA clarified what organizations qualify as SDOs.
• FDA clarified the required elements of a symbols glossary.

Permitting use of standalone symbols is an important step towards global harmonization of device labeling. We commend FDA for finalizing this important rule.  FDA also made the final rule more meaningful by, on the same day, updating its list of recognized standards to include several medical device symbols standards including, among others, ISO 15223 – Medical devices—symbols to be used with medical device labels, labelling, and information to be supplied—Part 1: General requirements. We expect this final rule to be embraced by industry.