New FDA Stand-Alone Symbols on Labels Regulations

Earlier this year, the Food and Drug Administration (FDA) ruled in favor of allowing companies to use graphical representation without added text on their products. This was done in part to bring more American companies in line with symbols that are currently being used in European and foreign markets. As more countries begin to use the graphic symbols, there will be increased cohesion between markets. The new ruling will go into effect on September 13, 2016.

Along with cohesion across markets, the FDA believes the new labeling will also save companies money in the long term. Instead of changing labeling over the years, the symbols will remain the same without a need to redesign a new one. The FDA has estimated medical device manufacturers will save between $7.7 and $25.5 million dollars over the course of 20 years.

The Standards Development Organization (SDO) has established labeling without explanatory text. If a company uses these symbols there will be further cohesion as they will be more convenient for companies to use, and it will give companies the ability to conserve resources. Should a company choose to use their own symbols, they are encouraged to make sure consumers will fully understand the symbols used. If there is any confusion; the company will be liable for any adverse events that occur due to misunderstanding of their symbol.

Along with each product, companies must also provide a glossary of the symbols and a description of where to find the glossary. Companies can further save money by offering the glossary online so they don’t need to worry about additional printing costs. This new FDA ruling gives companies an opportunity to save money in the future when they switch to a graphic symbol. Techprint

At Techprint we offer custom design and manufacturing for specialty graphics and printed electronic products.  We also offer sheet fed screen printing and roll to roll screen printing and converting to satisfy any label design requirements. To find out how Techprint’s capabilities can meet your needs, contact us.

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