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

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration is retaining its proposed requirement in a June 14 final regulation that any standalone symbols on medical device labels be explained in a glossary, despite industry arguments against that approach1. But the agency has added more flexibility to the breadth of symbols that can be employed by companies on product labels compared to a 2013 proposal.

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