How is the UDI Implementation Unfolding?

by Laura Johnson, on April 22, 2016

Screen_Shot_2016-04-22_at_8.59.11_AM.pngIt's been three years since the U.S. Food and Drug Administration mandated unique device identification for most medical devices distributed and used in the U.S. How has the process unfolded so far?

In 2014, Class III devices - which are typically high-risk components, such as replacement heart valves - were required to include a UDI labels on their packaging. One year later, all implantable, life-supporting or life-sustaining devices were required to have UDIs on their packages. Those devices that were designed for multiple uses had to be directly imprinted with a permanent marking.

Polls of companies affected by the regulation show that a large number still haven't been affected in any meaningful way. According to an article in Global Manufacturing, those who had been affected told pollsters that the process was challenging. Fifty-eight percent of those who were complying with the rules said that it was "difficult," while 4 percent even said that it was "extremely difficult." Only about one-third said that the process presented few challenges.

The next deadline is scheduled for Sept. 24, 2016. On this date, all Class III devices that are used more than once must bear UDIs as permanent markings. In addition, labels and packages for all Class II devices - which include personal wheelchairs - must also contain UDIs, and all data must be submitted to the GUDID database.

What can we learn going forward? Based on the polls' responses, we know that most companies foresaw the challenges that these regulations would bring. But they still need medical device labeling solutions to help them manage the regulatory complexity. An Enterprise Labeling Solution allows medical device manufacturers to centralize their labeling efforts and ensure compliance at a time when federal rules continue to change.

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Topics:Medical DevicesRegulatory