On June 14, 2016, the Food and Drug Administration (“FDA” or “the agency”) issued a final rule entitled Use of Symbols in Labeling. Historically, FDA regulations have only permitted use of symbols with immediately accompanying explanatory text. The new final rule modifies FDA’s regulations to explicitly allow for symbols in medical device and certain biological product labeling without adjacent explanatory text if certain requirements are met. This change in FDA regulations also harmonizes the U.S approach with international regulatory requirements, such as the European Medical Device Directive. Published in the Federal Register on June 15, 2016,1 the rule addresses the comments received from individuals, professional and trade associations, and industry in response to the proposed rule issued on April 19, 2013. The final rule goes into effect on September 13, 2016. The use of symbols is not mandated by this rule, but where manufacturers elect to use symbols on labels, the new provisions of this rule govern.
Specifics of the Revised Policy
Previously, symbols on medical device labeling were required by FDA to be accompanied by adjacent English-language explanatory text. The only exceptions to this were guidance documents allowing the use of a specific prescription use symbol and use of symbols for in vitro diagnostic (IVD) devices intended for professional use.2 The new final rule modifies FDA regulations at 21 C.F.R. Parts 660, 801, and 809 and allows for use of symbols established in a standard developed by a "standards development organization (SDO)3 " without adjacent explanatory text if:
- the standard is officially recognized by FDA and the symbol is used according to FDA’s statement of recognition for that standard4 ; or
- the symbol is recognized in an FDA standard but used in a way that is not consistent with the extent of FDA’s recognition, but the manufacturer determines that the symbol is "likely to be read and understood by the ordinary individual under customary conditions of purchase and use”; or
- the symbol is included in a standard that is not recognized by FDA, but the manufacturer determines that the symbol is "likely to be read and understood by the ordinary individual under customary conditions of purchase and use.”
In the second and third scenarios, the symbol must be used in a manner consistent with the specifications for its use set forth in the standard. The final rule does not allow for use of stand-alone symbols that do not come from standards developed by an SDO (commonly known as “proprietary symbols”).
In addition, any stand-alone symbol used in a medical device label must be explained in a “symbols glossary” (which may be paper or electronic) included in the labeling for the subject device. The symbols glossary should include:
- each SDO-established symbol used in the labeling for a given device;
- the title and designation number of the SDO-developed standard containing the symbol;
- the title of the symbol and its reference number, if any, in the standard; and
- the meaning or explanatory text for the symbol as provided in either FDA’s section 514(c) recognition or, alternatively, in the standard.
The labeling on or within the package containing the device must also include a "prominent and conspicuous statement" identifying where the symbols glossary is located such that a user will know where to look for reference.
Finally, the rule explicitly allows labeling of prescription medical devices to include "Rx only" or “℞ only” in place of the specific prescription use statement specified in 21 C.F.R. § 801.109(b)(1).5 Use of this alternative label was previously acknowledged by an FDA guidance document in 2000 and has commonly been applied by industry since then, but has not technically been permitted by the regulations until now.6
The final rule is largely consistent with the proposed rule of 2013, with the most significant change being the allowance of symbols established in standards which are not currently recognized by FDA if the manufacturer meets the criteria outlined above.
Graphics that are developed uniquely for a particular device outside the context of a standard or symbols that are beyond the specifications for use detailed in a standard are not covered by this rule and, if used to convey required labeling information, must be accompanied by corresponding text on the device label and potentially additional explanatory labeling.
Implications for the Medical Device Industry
The final rule allows for device labels to use stand-alone symbols to convey required device labeling information (e.g., expiration date, manufacturing site) so long as the criteria in the final rule are met as described above, which may allow manufacturers to take another step towards single global labeling for products. Manufacturers may also continue to provide explanatory accompanying text if they prefer not to update their labeling at this time.
FDA’s change in policy potentially enhances industry convenience and flexibility. The final rule applies equally to medical devices, including in vitro diagnostics, combination products whose primary mode of action (PMOA) is that of a device, and device constituent parts of combination products that are separately sold/labeled (regardless of the overall product's PMOA).
By vastly reducing the number of symbols that require accompanying explanatory text, implementation of the new rule may enable the design of more legible labels to communicate information to end users. In addition, one of the rule’s key benefits is that it promotes harmonization with global medical device labeling regulations (particularly those of the European Union). Manufacturers will now be able to use the same labels for U.S. and non-U.S. marketing of a given device without having to fit descriptive text – often in multiple languages – onto labels, a development that is likely to save industry both time and money. Of note, FDA on June 15 also updated its list of recognized standards to include several standards that establish medical device symbols, including ISO 15223 (Medical Devices – Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied – Part 1: General Requirements) (see table at left for some examples of commonly used symbols).
Furthermore, the expansion of the rule’s scope to include use of symbols as described in established standards that are not (yet) recognized by FDA will facilitate more timely availability of a greater variety of stand-alone symbols for use in device labeling. Where a manufacturer elects to use a symbol in a way that is inconsistent with FDA’s recognition of a standard or one that is not in a standard recognized by FDA, the manufacturer must determine that the symbol is "likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” The rule does not mandate that validation be performed that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use, but the preamble also makes clear that validation work is not prohibited. Thus, in such circumstances, manufacturers should carefully consider the type of support that would be needed to justify common understanding of the specific symbols.
In terms of implementing changes to the labeling, the final rule states that manufacturers who want to replace current labeling to include symbols without accompanying explanatory text would not need to submit a new 510(k) premarket notification or Premarket Approval (PMA) supplement for this change (though for a PMA device, the change should be explained in the next annual report). As this rule goes into effect only as of September 13, 2016, labeling using the “symbols alone” approach should not be commercially released until after this date.
The September effective date corresponds well to FDA’s September 24, 2016, date for implementation of Unique Device Identifier (UDI) requirements for class II devices. As companies work to redesign their device labels for compliance with FDA’s new UDI requirements, they may wish to take into account this new rule to use symbols alone in order to save additional space on the label, and also to take advantage of internal processing efficiencies that can be gained by bundling UDI revisions with transitions to the use of symbols in accordance with the final rule.