By Vince Velocci, MS
As of June 15, the FDA has revised device labeling regulations to allow for “stand-alone symbols” on labels and labeling in general and additionally for the symbol statement “Rx only” on prescription devices.
The industry has asked for and been granted the ability to use stand-alone symbols consistent with those placed on devices in jurisdictions outside the US. The rule will harmonize US requirements with the:
- European Medical Device Directive (Medical Device Directive 93/42/EEC)
- International Electrotechnical Commission (IEC 60417)
- International Organization for Standardization (ISO standard 7000-DB)
Until now, the agency has required symbols to have adjacent English explanatory text (medical devices and IVD for professional use). The change allows symbols developed by SDOs (standards development organizations) to be used as long as:
- The symbols are used according to specifications for use of symbols, as per FDA section 514, and the SDO is recognized by the agency; and
- When the symbol is NOT from an SDO or is but is NOT used as per FDA section 514 BUT the manufacturer determines that the symbol is likely to be understood by the “ordinary individual”.
In these cases, the symbol must be explained in a paper or electronic glossary. There must be a conspicuous English statement identifying the location of the glossary. It should be noted, that for articles distributed in Puerto Rico or other non-English Territory, the predominant language may be used.
In addition, the final rule allows the use of the symbol statement “Rx only” or “℞ only” for labeling of prescription devices.
DOLLARS AND CENTS
The agency expects the net cost benefits to be 6.6 to 22.3 million dollars (annualized over 10 years).
THE IMPORTANCE OF USABILITY TESTING – AN IMPORTANT TAKE HOME MESSAGE
CAN I USE NON-APPROVED SYMBOLS? Sounds like YES, assuming the symbols are recognizable by the target users and are included in a glossary which describes their meaning.
DO DRAWINGS AND PICTOGRAMS FALL UNDER THIS RULE? Instructions for use and quick reference guides often contain drawings and pictograms. These do not fall under these rules and can be used freely.
With both of these, presumably it is up to the vendor to provide evidence that their symbols and/or their pictograms are recognizable and understood by the target population. The best way to do this is formative testing. So test early and test often!