By Beth Wells

Class I medical devices—the largest– and perhaps most challenging medical device category—will soon be subject to enforcement of the FDA’s Unique Device Identification (UDI) rule. If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.

The first step is determining whether your product is, in fact, a Class I medical device. Considering the wide range of products included in the this category, it is not always obvious that a product would fall under the FDA’s medical device definition, which includes any item that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”

Class I medical devices are those posing the lowest risk to patients and/or users, compared to Class II (moderate to high risk) and Class III (devices that sustain or support life, are implanted, or present potential high risk of illness or injury). The FDA provides guidance on its website to help users determine whether a product qualifies as a medical device and therefore is subject to the UDI Rule. 

Class I medical devices include a huge array of products ranging from tongue depressors to exam gloves, and they are made by companies of all sizes; some produce hundreds of medical products and some only a few. The broad definition of Class I products creates special challenges not encountered with Class II and III devices: not only determining whether the product meets the definition, but also addressing the identification, marking, and data requirements for a huge category of qualified products, which must be uniquely identified and uploaded to the FDA’s Global Unique Device Identification Database (GUDID). Industry experts anticipate that uploading Class I UDI data, when completed, could double the 2.3 million device identifiers currently stored in the GUDID. With such an abundance of data to collect and upload, planning is needed. 

Why It’s Important

The UDI Rule was passed in 2013 with the intent of improving patient safety by making healthcare products traceable throughout the supply chain to point of use. Without UDI, it would be impossible to know exactly where a medical product is located at a given time and to monitor its sale at retail and distribution and use in patient care. This information becomes critical in the event of a recall as well as in the medical community’s ability to track a product’s effects in patient or consumer use. 

Unique identification enables retailers to quickly and accurately pull recalled products from shelves without wasting products that are not affected—a benefit for manufacturers, retailers, and consumers, who will be able to shop with confidence knowing that the products on the shelf have not been impacted by an adverse event or recall. In the healthcare provider setting, where Class I products are used constantly in the delivery of even the most basic care, UDI improves patient safety by facilitating accurate tracking and removal of products that have expired or been recalled. 

UDI information will provide the backbone for interoperable data exchange between suppliers, distributors, and providers, as the rule requires by 2023. Fully implemented across the entire healthcare ecosystem, the UDI Rule will ultimately improve patient safety, modernize device monitoring, and facilitate operational efficiencies for healthcare providers. 

Class I UDI Requirements

Since Sept. 24, 2018, under the UDI Rule, most Class I medical devices—except those exempt by regulation from good manufacturing practice (GMP), for example—must be labeled with a unique device identifier (UDI) in a human-readable and machine-readable automatic identification and data capture (AIDC) format such as a barcode and be registered in the GUDID. According to the GUDID, 86% of companies currently use a GS1 Global Trade Item Number (GTIN) for the product identifier. The FDA delayed enforcement for two years to give companies time to learn, prepare, and implement the new requirements correctly. That grace period ends on September 24.

In addition to the labeling, all device manufacturers are required to upload a significant amount of specific data for every medical device to the GUDID. The GUDID is designed to capture information about as many as 62 product attributes. Seven are auto-populated from login credentials; 18 are required; 24 are required conditionally based on responses to the 18; and 13 are optional. The volume of data points to be gathered and uploaded to the GUDID is substantial, particularly for companies with multiple product lines. Once entered, the data for all those products also must be maintained so that it will always be up-to-date and accurate. 

Getting Started

Compliance deadlines were set in stages, according to the device classification, so that the more critical (Class II and III) products affecting patient safety were first in line to implement the necessary requirements. Any manufacturers that also trade Class II or Class III devices have already implemented UDI for those (higher-risk) products, and their experience will make this Class I implementation phase easier. Regardless, collecting and entering the data to the GUDID is not a small undertaking. 

The first UDI requirement, the assignment of unique product identifiers with the prescribed data elements in a barcode, is familiar to most companies producing or distributing Class II and Class III devices and products that are sold at retail. Retail products are already labeled with UPC barcodes carrying a GTIN-12. The FDA has deemed the GTIN-12 and UPC barcode to be sufficient for meeting the requirements of UDI for Class I devices. UPC barcodes are incapable of being encoded with production information or additional data such as expiration date, production date, lot/batch number, or serial number. However, if this type of information is used in the supply chain management of a Class I device, it will need to be indicated as such in the GUDID details about that device. 

Next, a FDA labeler account must be established. Then with the UDI in hand and a summary of the additional attribution that will be needed for each device, the GUDID input can begin. There are three different approaches to tackling this work: assign someone to do it internally via a GUI interface, automate the process using a proprietary business-to-business interface program based on HL7 code, or hire a third-party service provider to do it. Companies with fewer than 100 products may find the do-it-yourself approach most practical. Every manufacturer will need to choose an approach that fits its budget, staffing resources, and volume of products to be recorded and maintained.

Logging into the FDA website to enter the product data, users will find a workflow path that leads them through the questions to be answered. The most time-consuming aspect of the entire process for most companies will be collecting the required information before uploading the data.

Several resources are available to help guide companies through the process. GS1 US offers an Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI) and a Quick Start Guide explaining how GS1 Standards can be applied to meeting the UDI requirements. The FDA also offers guidance in its online resources FDA UDI Basics and Global Unique Device Identification Database (GUDID): Guidance for Industry

Considering the vast range and potentially large volume of Class I medical devices that will soon be held accountable for meeting UDI requirements, there is no time to waste. Manufacturers of these countless products need to act quickly in order to be ready when FDA enforcement begins. 

Beth Wells is senior director of community engagement, healthcare, at GS1 US. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at [email protected]