Do All Justifications for Direct Marking on Implants Have to be Submitted to the FDA or Can They be Documented in a Device History File for Inspection by the FDA?

The UDI Rule says that you need to have a permanent UDI on the device itself.

Direct Part Marking (DPM), is a set of technologies that are used both in medical device space, and widely in the DoD space, to apply typically bar codes to often metal or hard surfaces. One of the technologies to apply barcodes to surfaces is laser etching. There’s a number of different technologies that are out there.

But direct part marking is one way to meet the direct mark requirement. Obviously, there are permanent labels, tags, other ways as well, and some of this is discussed as well in the FDA's guidance on the topic.

On the issue of exceptions built into the Rule, I didn't touch on them today, but just like the single-use vice packaging and convenience kit exception, integral to the UDI Rule are a number of direct marking exceptions. They are listed there. And just like the single-use device packaging exception or the convenience kit exception, these exceptions are noted in the DHF of the particular device. So if you decide, for example, that it is not technologically feasible to directly mark your device, this is something you note yourself. All of these exceptions are things, all the exceptions that are integral to the Rule are things that you note yourself and do not have to request from the FDA.

There is an exception and alternative process that is built into the Rule, so if for some reason you believe you can't meet the Rule as we just talked about it and the exceptions that are integral to it are not sufficient, you can request from FDA a specific exception alternative. We've done a number of those for clients. There's some more information on FDA's website. If you have questions about it, please let us know.

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.