In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA refers to these as “stand-alone symbols.” In the past, the FDA allowed the use of symbols only with adjacent explanatory text. The final rule is an effort to harmonize domestic and international labeling requirements, which is anticipated to result in significant cost savings to manufacturers who opt to use these stand-alone symbols domestically.
What Symbols Are Allowed Under the Final Rule?
Stand-alone symbols may be used in two circumstances. First, a symbol may be used if it is established in a standard developed by a standards development organization (SDO), the standard is recognized by the FDA, and the symbol is used according to the specifications for use of the symbol.
Alternatively, if the symbol is not included in a standard recognized by the FDA, or is not used according to the specifications for use of the symbol, the stand-alone symbol may still be used if the device manufacturer determines that the symbol is “likely to be read and understood by the ordinary individual under customary conditions of purchase and use,” and the symbol is established according to the specifications for use of the symbol set forth in the standard developed by the SDO.
In either situation, the symbol must be explained in a glossary that is included in the device labeling, and the labeling must include a prominent and conspicuous statement identifying the location of the glossary. Further, the symbols must comply with labeling requirements, similar to any text used in device labeling.
Also, manufacturers may use the symbol statement “Rx only” or “℞ only” for labeling prescription devices, rather than the longer statement that is currently required by the regulations.
Are Manufacturers Required to Use Stand-Alone Symbols?
The use of stand-alone symbols under this rule is optional. Device manufacturers may continue to omit symbols entirely, or use symbols with adjacent explanatory text. The decision about whether to use stand-alone symbols comes down to a cost-benefit analysis for manufacturers.
What Does This Mean for Medical Device Manufacturers?
The good news is that because this new rule is not mandatory, manufacturers are not obligated to make any changes or to meet a particular deadline. Manufacturers are free to consider whether the use of stand-alone symbols provides a positive net benefit and can take time to implement any desired changes in labeling.
If a manufacturer does change its labeling under this new rule, the manufacturer will need to consider whether any additional regulatory submissions are required. At this point in time, the best answer to that question is maybe. The FDA has indicated that in most cases, manufacturers wishing only to substitute existing text with a stand-alone symbol or to remove explanatory text are not required to make a new submission or a supplement to the FDA before making the change. But the FDA will determine on a case-by case basis whether to require specific language in labeling or prohibit the use of symbols in a given context. Until further information is available, manufacturers of both 510(k) and PMA devices will need to carefully assess any labeling changes under this rule to determine whether a new or supplemental submission is necessary. Certainly, for PMA devices, the PMA holder should notify the FDA of the change in their general annual report.
Device manufacturers also should consider whether the stand-alone symbol to be used is contained in an FDA- recognized standard and whether that symbol satisfies the specifications for use contained in that standard. If the symbol is contained in an FDA-recognized standard and is used according to the specifications of that standard, then the FDA has already determined that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. That is the simplest application of the rule. Beyond that, a manufacturer may be required to submit a declaration of conformity to the FDA and/or to satisfy the subjective burden that a symbol used is “likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” Certainly, if a manufacturer elects to use a symbol that is outside of an SDO standard, the manufacturer should anticipate that the FDA will enforce compliance.
Whether the use of stand-alone symbols has any product liability implications remains to be seen. There is no private right of action for failure to conform to FDCA, but whether a plaintiff could pursue a failure to warn claim premised on the use of a stand-alone symbol likely will depend on what information the stand-alone symbol seeks to convey, the content of other warnings and information provided along with the device, and whether the physician read and understood the labeling.
In sum, the FDA’s final rule allows device manufacturers to use stand-alone symbols, without adjacent accompanying text, when certain requirements are met. The final rule is not mandatory, so a manufacturer is free to continue to use text-only or explanatory text if it chooses. If the manufacturer decides to replace text with stand-alone symbols, it should consider the need for additional or supplemental premarket submissions and the extent to which its stand-alone symbols meet or deviate from FDA-recognized standards.
The rule is effective September 13, 2016.