[Video] What's next for UDI Compliance?

by Jessica Plourde Hutter, on February 10, 2016



Last week, we discussed the importance of the FDA's UDI compliance and how they have applied to the medical device industry. Now we'll look at what comes next.

On September 24, 2016 — three years after the publication of the final UDI rule — a number of new provisions will go into effect. Manufacturers of Class II medical devices like surgical needles and infusion pumps will be required to include a UDI label on all products and packages. 

In addition, Class III medical devices will have to bear a UDI as a permanent marking, but only if the device is intended to be used more than once.

UDI compliance involves many complicated steps. Check back next week for more about what manufacturers should expect, and how Enterprise Labeling Solutions can help.

To find out more about UDI labeling check out our webinar featuring GHX.

Download the Webinar - Ins & Outs of UDI

Topics:Medical DevicesRegulatoryLabeling