As noted in my last blog post, the final rule for Unique Device Identification (UDI) was published today, September 24, 2013, to the Federal Registry. Which means the clock is now ticking.
Within one year (by September 24, 2014) all Class III medical devices must bear a UDI.
Within two years (by September 24, 2015) Class II and Class I implants and life-sustaining devices must bear a UDI.
Within three years (by September 24, 2016) remainder of Class II devices must bear a UDI.
Within five years (by September 24, 2018) Class I devices must bear a UDI.
There are some exceptions. The industry has been given three years to make existing inventory compliant. Class I devices do not need to include production identifiers and thus will not require dynamic printing/packaging. Shipping containers are exempt. Individual single use devices, such as ones that come in shelf packs, are exempt.
One of the most notable exemptions was related to kits and combination products. If there is a UDI on a kit or combination product then the constituent parts are exempt from having UDI.
There is no longer any reason to delay. The time to begin implementing UDI is now. If you’re in search of a solution or would like to understand more, please contact us.
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