FDA Finalizes Device Symbol-In-Labeling Rule Retaining Glossary Requirement
This article was originally published in The Gray Sheet
Industry complaints that a 2013 FDA proposal calling for a glossary explanation for standalone symbols used in device labels went beyond internationally harmonized standards did not persuade the agency to drop the glossary from its June 14 final rule, but FDA does provide more flexibility on symbols that can be employed in device labeling.
You may also be interested in...
US FDA is reopening the comment period on a rule that allows medical device manufacturers to use standardized symbols on product labeling. The docket will be open through May 20.
While device firms say FDA’s proposed rule on symbols in device labeling is needed, they say additional requirements for explanations of symbols in an accompanying glossary are duplicative.