FDA Final Rule

In this blog, “What is UDI and Why It Matters,” the author reviews the fundamentals of UDI, FDA’s Final Rule applications, and its global significance. 

FDA’s Final Rule (Federal Register – UDI Definition) states a Unique Device Identifier (UDI) is a code that sufficiently identifies a medical device throughout its distribution and use. The UDI is comprised of a static component, “Device Identifier” (DI), and a dynamic component, “Production Identifier” (PI). 

The DI itself is made up of your Labeler Identification Code and a code that pinpoints the specific version or model of that device. PI, on the other hand, includes manufacturing information for that specific device, such as lot or batch number, serial number, expiration date, or manufacturing date (both in YYYY-MM-DD format).

Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a medical device requires the use of the ISBT-128 format UDI. The UDI Final rule requires medical device labels to contain a UDI, unless exempt or provides for an exception or alternative placement. The UDI must be both human-readable and in a form that uses automatic identification and data capture (AIDC) technology. 

Reprocessed and Single-Use Devices

Medical devices that are both used more than once by intention and reprocessed by intention must have the UDI directly marked on the device. The Final Rule details exceptions to this requirement (Federal Register – Direct Marking Requirement). UDI does not need to be on individual single-use devices. Instead, it needs to be located on the next higher package. For example, non-sterile exam gloves would require a UDI on the box label, not each glove. 

This section of the rule stipulates individual single-use devices, all of which are the same version or model, must be distributed together in a single device package, is intended to be stored in that device packaging until removed for use, and is not intended for individual sale.  However, it does not apply to implanted devices, which require a UDI on the package of the individual device. Federal Register – Single-use Device 

Stand-Alone Software

Stand-Alone Software that is regulated as a medical device, must also bear a UDI. The software version should be included in the production identifier. If the software is downloaded from a website, the UDI must be in plain text (i.e., not in AIDC format) and displayed whenever the software is started and/or in the plain text displayed through a menu command, such as the “About” screen. If Stand-Alone Software is sold in a package, the package must have the UDI on its label. However, the DI of packaged software may be identical to the downloaded version. Federal Register – Stand-Alone Software

Why Now? Why Does It Matter?

Some medical device companies, especially distributors, obscure manufacturers’ names and item codes on device labels. Different devices might have the same item code, while the same device might have different item codes. These inconsistencies confuse healthcare professionals—especially during recalls and adverse event reporting. Therefore, FDA and other regulatory agencies are implementing UDI regulations to:

• Improve patient safety by reducing medical errors.
• Strengthen the Electronic Medical Records initiative by providing a standard method for recording the identity of each device during use in clinical information systems, claim data sources, and registries.
• Address counterfeiting and diversion
• Prepare for medical emergencies and disasters
• Provide a foundation for a global, secure distribution chain. 

The most important reason for UDI regulations is the need to improve the accuracy and timeliness of Post-Market Surveillance (PMS) data. More accurate and timely PMS data will indirectly improve patient safety by helping facilitate more accurate reporting, reviewing, and analyzing of adverse event reports, so problem devices can be pinpointed, corrected, and removed faster. 

Impact of UDI Regulations Globally

FDA hopes the UDI regulations will lead to the development of a globally harmonized medical device identification system that is recognized around the world. The European Union and regulatory agencies around the globe are drafting their versions of a UDI regulation. In addition to the benefits of implementing a UDI system in general, a global UDI system would:

• Allow companies to create globally harmonized labeling with a single UDI worldwide
• Promote worldwide tracking and tracing of devices for easier recalls
• Provide another risk control to prevent counterfeiting and diversion of medical devices

To that extent, the International Medical Device Regulators Forum (IMDRF) published their UDI Guidance document IMDRF UDI Guidance Document, which has many similarities to the FDA Final Rule.

The Unique Device Identifier Final Rule is more than just a new FDA regulation—it is also good business practice. Healthcare customers are embracing the use of unique identifiers. In past experiences with implementing GTINs (another form of UDI from the UDI issuing agency GS1), customers demanded implementation of GTINs, or they would find a new supplier. Manufacturers may choose to ignore one or two customers. Still, eventually the number of customers demanding UDI will be significant, and they will need to act quickly—regardless of FDA deadlines.