FDA Proposes to Harmonize Medical Device Labeling

By Jennifer D. Newberger –

FDA is proposing to amend the medical device labeling requirements to allow for use of internationally recognized stand-alone symbols explained in an accompanying symbols glossary.  The symbols glossary would include a list of each symbol used in the device labeling and an explanation of the symbol’s meaning.  The permitted symbols would be those recognized by a standards development organization (“SDO”) such as the American National Standards Institute (“ANSI”) and the International Organization for Standardization (“ISO”).  FDA will retain a list on its website of the standardized symbols it recognizes.

Allowing use of these symbols is intended to harmonize medical device labeling with European Union requirements.  Currently, stand-alone symbols are generally not permitted on medical device labeling in the United States; any symbols used must be accompanied by text directly on the label.  In Europe, however, stand-alone symbols are widely used.  According to FDA, the inconsistent requirements result in manufacturers having to revise their label for the U.S. market, which has “created confusion and generated industry complaints that manufacturers have to develop different labels for each market.”

The proposed rule provides the option to continue labeling devices as they have been—symbols with accompanying text—or to use stand-alone symbols explained in an accompanying symbols glossary.  In other words, FDA will not require manufacturers to use stand-alone symbols for devices in the U.S. market if they do not wish to do so.  For global manufacturers, however, the ability to create one label for worldwide distribution (not taking into account necessary language differences) will likely be a welcome relief.