The rise of mobile devices has changed more than just how people browse the Internet. It’s changed branding, logo design, and brought about an increase in the use of icons in place of text. With smaller screens, space is at a premium. Users rely on web conventions, like the hamburger menu, to know how to navigate in this emerging space. Likewise, as the need for both apps and social channel icons increase, there’s been a shift toward more icon-like logos. The redesign of Netflix’s logo is one example. But when it comes to medical device packaging, is relying on symbols appropriate?
According to the recent FDA ruling, it is.
What This Means for Medical Device Packaging
As laid out in their 80-page ruling, medical device packaging can now use stand-alone symbols in labels, without explanatory text. Going into effect in September of this year, the ruling states that any symbols used must be “standardized.” This means that it must have undergone approval from a national (or international, if the product is sold across borders) standards development organization. What makes this notable is that the FDA is specifically saying that they don’t personally need to approve the symbols.
This is good news for medical device packaging manufactures, like Minnesota-based Sunrise, because it’s more convenient and symbols can be approved more quickly. Medical device packaging is notorious for many strict guidelines, so anything that can help the process is a win. Additionally, the use of symbols reduces the need to design and redesign packaging (according to Lexology). In fact, it’s estimated that medical device manufacturers will see benefits in the range of $6 to $20 million dollars over the next 20 years.
It also means that medical device packaging doesn’t need to include multiple iterations in different languages for explanatory text. Symbols have long been in use in foreign markets. This ruling helps build consistency or “harmony” the U.S. device labeling requirements for symbols with international regulatory requirements. Law experts from Hyman, Phelpsde and McNamara commented in a post on FDA Law Blog:
Permitting use of standalone symbols is an important step toward global harmonization of device labeling. We commend the FDA for finalizing this important rule.
With the ruling coming into effect in September 2016, there are a few things medical device packaging and manufacturers can do. Symbols need to be validated by a standards development prior to use, so consultation is one step. To ensure that the user base understands the symbols, validation studies will help ensure that the symbol is intuitive and the meaning is clear. This is recommended, as the FDA may still monitor post-market surveillance data if consumers can’t understand the symbol or if it’s deemed misleading. Glossaries (including online) are also required with the use of symbols; development can begin as soon as an organization is ready.
Using symbols in medical device packaging benefits not only the manufacturer but also the consumer…as long as the symbols are well-designed. It’s much easier to glance at a product and process its function than it is to read lengthy instructions. It will be interesting to see how symbols figure into the future of medical device packaging.