Under a final rule, device labels marketed in the US may use a symbol without adjacent explanatory text. This new rule, which goes into effect on September 13, 2016 Revises Part 660 Additional Standards For Diagnostic Substances For Laboratory Tests, Part 801 Labeling, and Part 809 In Vitro Diagnostic Products For Human Use.
The new rule does not require a label but allows an option. Some conditions apply to exercise the option.
- The symbol comes from a recognized standard and the use conforms to the standard.
- The symbol comes from an unrecognized standard, the use conforms to the standard, and the manufacturer determines “the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use”.
- The symbol comes from a recognized standard, the use is NOT in conformity with the standard, and the manufacturer determines “the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use”.
In all these cases, the manufacturer prepares a glossary of the symbols and meanings and makes it available as part of the device labeling.
In conjunction, Recognition List No. 42 modified the recognition of five standards and added three standards.
https://www.gpo.gov/fdsys/pkg/FR-2016-06-15/pdf/2016-13990.pdf