The Medical Device industry is highly regulated and presents constantly changing regulatory challenges in which manufacturers need to comply. Earlier this year, in fact, the U.S. Food and Drug Administration’s announced their final ruling, “Use of Symbols in Labeling,” which allows for the use of stand-alone symbols in medical device labeling, without the need for adjacent explanatory text. To meet these specific regulatory requirements, your labeling and coding needs to adapt. Hughes and ID Technology offer custom identification equipment for efficient, reliable labeling and coding performance.
The FDA’s recent rule requires that manufacturers label a medical device with a UDI (unique device identifier). But now, medical device packaging can use graphical representation of information (symbols) in labeling without explanatory text. A stand-alone symbol may be used but only if it is “standardized” and approved from a national (or international) standards development organization.
The FDA also published a new standards-recognition notice that modifies the agency’s current list of recognized standards containing stand-alone symbols to extend the recognition of six standards and to recognize three new consensus standards containing many more stand-alone symbols. Along with each product, companies must also provide a glossary of the symbols and a description of where to find the glossary.
Primary and secondary packaging must conform to these requirements to ensure device tracking and traceability. Secondary packaging, such as cardboard boxes or cardboard cartons, keep the primary packaging safe during transport.
With ID Technology, labels can be applied to any sides of the box (or all sides) as it goes through your production line for character printing on demand. At Hughes Enterprises, we have a unique partnership with ID Technology allowing us to offer our customers only the best.
Designed for small character coding applications in industrial products, the iCon laser offers a reliable alternative to inkjet. Because it doesn’t use consumables or solvent emissions, costs stay low and the lasers require minimal maintenance.
The ID Technology iCON Laser Coder can print either statically or dynamically. It uses MarcalLite software which allows you to print four lines of text, logos, alphanumerics and graphics such as those required in the new UDI ruling.
Both ID Technology products print permanent codes at high speed. They have proven, high performance optics. Because of the new FDA ruling, companies now have an opportunity to save money and time as they switch to graphic symbols in Medical Device Packaging.
At Hughes, we offer a wide variety of case labeling equipment solutions for Pharmaceutical and life sciences. We want to meet all your medical device packaging demands and satisfy any label design requirements. Find out how Hughes capabilities can meet your needs, contact us at
Need help deciding which ID Technology labeling equipment is right for you? Give us a call at 267-409-6100 to speak to one of our packaging consultants and engineers.
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