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FDA Finalizes Device Symbol-In-Labeling Rule Retaining Glossary Requirement

This article was originally published in The Gray Sheet

Executive Summary

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.


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