FDA Issues Clarifying Guidance Before UDI Deadline

We’re just over one month away from the next UDI deadline, which means medical device manufacturers are running out of time to make sure they are in compliance. Given the complexity of many of these devices, and the health needs of the patients who use them, it is vital that the industry gets this process right.

Durafast plans to offer a new software solution to help businesses simplify their barcode labeling.

By September 24, 2016, all Class II medical devices will be required to bear UDIs on their labels and packages. This class of devices is a significant one, covering 43 percent of the market and including such common items as powered wheelchairs and pregnancy test kits.

The purpose of the UDI is to ensure both care providers and patients have an easy way to retrieve identification, tracking and tracing data from the GUDID database – thus reducing medical errors and improving care.

Last month, the U.S. Food and Drug Administration issued a draft guidance that clarified certain UDI requirements. According to a report by Healthcare Dive, UDIs must take the form of both plain text and a scannable AIDC version. If one label is too small for both, they may be attached separately. 

Next month, Durafast plans to offer a new software solution that will help businesses simplify their barcode labeling and comply with UDI regulations. NiceLabel 2017 will streamline the printing process to control costs and eliminate errors.

With regulatory deadlines approaching, you need the right printers. Durafast offers printing solutions that help you produce exactly what you are looking for. Contact us today!