Use of Symbols in Product Labeling

The FDA recently tweeted that it is seeking feedback on the use of symbols on device manufacturers’ products and in their instructions for use. There are pros and cons to this. Advocates say that the use of standardized symbols allows comprehension across language barriers, while critics say that even symbols commonly used on medical devices may not be adequately understood by their intended users.

When developing your labeling, consider your target audience.

Are they medical professionals who see those symbols regularly, or are they lay-people who may never have seen them before? Do you expect your device to be used by people speaking different languages? Will the symbol be understood to mean the same thing across all those languages?

Consider the importance of the information on the label.

If someone were to misunderstand the symbol, what could happen? Misunderstanding leading to imminent harm is far different from misunderstanding having little to no effect. Finally, consider the symbol itself: Is it readily obvious what it means, or does it leave room for interpretation? These are a few ways you can decide whether it is safe to use symbols in your device labeling.

Realtime believes that the user experience and the safety of user and patient alike should ultimately drive our designs and our labeling. Our engineers have vast experience designing medical devices in compliance with IEC 62366-1 and other standards. Give us a call at (972) 985-9100 and let us help you with your device design needs.