Devices

Labeling Options for Medical Device Symbols

Two CDRH officials say that under a new Use of Symbols in Labeling final rule, medical device manufacturers have three options. Senior policy analyst Antoinette Hazlett and health standards program director Scott Colburn say in an FDA Voice blog post that companies can (1) choose not to use symbols, (2) use symbols with adjacent explanatory text, or (3) use standalone symbols that have been established in a standard if certain requirements are met, including providing a symbols glossary as part of the device labeling that gives an explanation of the symbols.

“Adding the option of standalone symbols is expected to reduce design costs for manufacturers because it is more consistent with how devices are currently labeled in Europe and other foreign markets,” the two write. “Replacing small and difficult-to-read text with a symbol will also help make some labeling more user-friendly and understandable. That is critical in medical device labeling, where space may be limited.”

Before the rule, the post says, FDA recognized five consensus standards addressing the use of standalone symbols. Concurrent with issuing the rule, it updated the list of recognized consensus standards by adding three new standards containing more symbols.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome