Unique Device Identifier Final Rule-FAQs-Part I

This blog, “Unique Device Identifier Final Rule-FAQs-Part 1,” answers questions, such as, what is a UDI? Who is responsible for applying the UDI label? Etc. 

What is a “UDI?”

The Unique Device Identifier (UDI) adequately identifies a device throughout the supply chain and while in use. It is constructed of two main sections – a device identifier and a production identifier. The device identifier is comprised of a permanently assigned product code (model or version) and a labeler identification code. The production identifier is a dynamic component and made up of a lot number, serial number, manufacturing date, expiration date, etc. The device identifier and production identifier together make up the UDI.  Federal Register – Unique Device Identifier definition

Who is responsible for applying the UDI label? 

FDA has defined the “Labeler” to be the entity responsible for applying the UDI label. This entity may or may not be the actual manufacturer. The Labeler is defined as the entity that causes a label to be secured to a device and who places the device into commercial distribution with the expectation the label will not be replaced or modified in any way. Additionally, should an entity replace or substantially modify the original label, and then place the device into commercial distribution with the expectation the label will not be replaced or modified in any way is also a Labeler. Distributors who simply add their name and address to the package are not defined as a Labeler under this definition. 

Private label devices present a situation where the actual manufacturer or brand name holder can be the Labeler. This would be a business decision between the manufacturer and the brand name holder. The Labeler may also be the specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.  Federal Register – Labeler definition

What does a “standardized” date format mean? 

FDA has decided for all human-readable dates (manufacturing date, expiration date, etc.) printed on labels must follow a YYYY-MM-DD format. The DAY is an absolute requirement. For example, March 31, 2014, must be presented as 2014-03-31. This requirement applies to ALL medical device classes that use a date on their label. Federal Register – Date format definition

I have kits that are comprised of several devices; how does this rule apply to me?

There are many types of kits. Kits can be made up of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to expedite a single surgical or medical procedure. §801.30(a)(11) states when a device is packaged within the “immediate container of a combination product or convenience kit, the label of the device will not be required to bear a UDI,” as long as the label on the kit has a UDI. Should your kit have a National Drug Code (NDC) number on its label, it does not also need to have a UDI.  §801.30(b)(3) clearly states devices that are included in a combination product with an NDC number on its label and does not have a UDI; the device components must bear a UDI on its label. Federal Register – Kits Exemption

What does reprocessing mean? 

FDA uses the term “reprocessing” in conjunction with a direct marking of a unique device identifier. Devices intended to be used more than once must have the UDI permanently marked directly on the device (with a few exceptions), and will be reprocessed between each use. However, the FDA has not yet defined what “reprocessing” means. I have asked FDA this question, with their response being they will “shortly” issue additional guidance on this matter. When they do, I will let you know via this blog. Until they do, use the following definition of “reprocessing” – clean, clean plus disinfected, or clean plus sterilized. Federal Register – Direct Marking and Device Reprocessing

We sell software that is considered a medical device; how do I label these devices?

Stand-Alone Software (SAS) regulated as a medical device must also have a UDI. SAS that is downloaded from the web and/or sold packaged must use the version number (as the lot number) in its production identifier. The full version of the UDI must be displayed in easy-to-read plain text, following the rules of the issuing agency you have selected, on the start-up screen and/or a menu command screen, such as the “About” screen. The UDI on the SAS packaged form may have the same device identifier. Federal Register – Stand-Alone Software

What is a device package? 

A device package is a package that contains a fixed number of a specific version or model of a device. The use of this term has often confused people who think it has something to do with the package design. Federal Register – Device Package definition

Do I need to label our shipping containers? 

A shipping container, for this regulation, is defined as a container used to ship or transport devices in which the items within may change from one shipment to another. The rule does not require a UDI label for any shipping container. Federal Register – Shipping Container