FDA Finalizes Symbol Rules for Medical Device Labeling

The medical device market is massive. Recently, healthcare market researcher Kalorama Information estimated that the market reached a total value of $381 billion in 2015, and growth looks poised to continue.

In particular, wearable medical devices – such as heartbeat monitors or glucose measuring systems – are growing in popularity and could be worth as much as $24 billion this year, according to Future Market Insights.

To ensure safety and regulatory compliance, the U.S. Food and Drug Administration is in the process of finalizing labeling rules that match those that have already been put in place by other international bodies. For instance, Packaging World reports that the FDA just issued its final rule on the use of symbols in medical device labels. This will allow certain device manufacturers to apply symbols without necessarily adding text to explain what they mean.

The FDA just issued its final rule on the use of symbols in medical device labels.

One advantage of this rule is that medical device manufacturers can use recognizable symbols to convey important information without having to worry about clarity of writing. They also don’t have to wonder whether the user speaks the same language.

Instead, they can point consumers and medical professionals to paper or electronic glossaries, which will contain definitions for all of the symbols that may appear on applicable devices. Once users learn all of the symbols, they will be able to recognize their meaning at a glance – in less time than it would take to read even a short warning passage. 

It’s important for manufacturers to have the capability to print labels that adhere to FDA rules – especially when color is required. Durafast offers printing solutions that help you produce exactly what you are looking for in a cost-effective manner. Contact us today!