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Would an A/C Adapter That Can be Sold as a Replacement Need a UDI?

There are no hard and fast rules here. A manufacturer has to decide where certain things fit. Now, there are obviously certain accessories already identified though the classification regulations and through the product codes. So there are some things that we already know are accessories, where we don't have to guess whether ventilator tubing, for example, is an accessory. It's already identified as such.

It's a very small proportion of all of the parts that are out there are actually separately identified as accessories from a regulatory perspective. So some things we could probably look at easily and say they're not an accessory. So if we think about a replacement panel for the back of a device. Right? I think we could all look at that and go "Well, okay, that's a replacement panel. That has no effect on the performance of the device. It's a spare part or replacement part.” And on the other end, we can probably say pretty easily that something like ventilator tubing is an accessory.

In between there's this just enormous gray space. Jay Crowley, Vice President of UDI Services and Solutions and the architect of the UDI Rule says he just can't answer that question for medical device companies. You're going to have to decide by going through this process following whatever SOP you put in place and documenting this and we've used different processes with different sets of criteria, depending on the client. You're going to have to go through and decide whether something that is individually distributed is an accessory or is not. And Crowley thinks it's important to look not only at the actual words that are associated with it, but the intent of the Rule and how your customers are going to react to some things being UDI compliant and some things not.

Unfortunately, without a lot more information and understanding of your specific devices, there are no hard and fast rules here, aside from things being obviously identified as accessories already from a regulatory perspective. It's really a process and each manufacturer needs to decide how this is going to work for them.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.