FDA gives companies more time to switch from old medical device IDs
by Laura Johnson, on March 1, 2016
In 2013, the U.S. Food and Drug Administration finalized its UDI rule, requiring medical device manufacturers to bear labels containing device identifiers and production identifiers.Initially, the rule established a seven-year process during which manufacturers would make the slow transition toward labeling the packages of different classes of medical devices, before finally affixing permanent labels to the devices themselves. However, the effort may ultimately take even longer than that, thanks to the FDA's implementation delays for certain products.
For instance, this month the FDA gave medical device manufacturers more time to transition away from the use of NHRIC and NDC numbers on certain devices. The former, part of the National Health Related Items Code, and the latter, part of the National Drug Code, were used to identity devices and pharmaceuticals before reform.
"The prohibition of NHRIC and NDC labels ... will not be enforced until September 24, 2021."
Under 21 CFR 801.57, manufacturers are prohibited from using the aforementioned legacy FDA identification numbers. The agency believes that leaving these identifiers alongside UDIs would only lead to confusion. But many manufacturers and care providers have raised objections, arguing that the initial timeline would be disruptive and prevent some patients from accessing necessary devices. The prohibition of NHRIC and NDC labels on products manufactured before September 24, 2018 will not be enforced until September 24, 2021.
Given the complexities inherent to the medical device supply chain, it would hardly be a surprise if the FDA made further adjustments to the UDI rule in the coming years. Loftware, a certified GS1 partner, can help manufacturers remain in UDI compliance. Our Enterprise Labeling software provides an end-to-end supply chain labeling solution that meets the specific needs of medical device manufacturers.
For more information on medical device labeling, listen to our on demand webinar "The Ins and Outs of UDI: Achieveing Value through Compliance."