With the release of the Unique Device Identification (UDI) System Final Rule in 2013, manufacturers have been staring down compliance deadlines that are quickly approaching and scrambling to make sense of the new regulations. The backlash of failing to achieve compliance with the UDI regulations will be detrimental to manufacturers. Noncompliance will allow the FDA to prohibit noncompliant manufacturers from selling products across state lines and from importing devices into the US [1,2]. Beyond losing sales to compliant competitors, the damage to the manufacturer’s brand and reputation could ultimately lead to its demise . Thus, all device manufacturers must achieve UDI compliance before the deadlines documented in the final rule.
According to 21 CFR 801.20, every medical device and device package must bear a UDI; exceptions are detailed in §§ 801.30, 801.45, 801.128(f)(2), and 801.55. Manufacturers must create a UDI for each product version, variant, and packaging configuration . This is a daunting task for even the simplest devices. Band-Aids for example, require a UDI for every version of the Band-Aid, whether the variances between them are dimensional, material, or packaging related. Additionally, every time a manufacturer refines a product, the UDI submission will have to be repeated. Not only is a UDI required on a device and package, key device identification information must be submitted to the Global Unique Device Identification Database (GUDID). The GUDID is a publically accessible repository for specific device information; 62 data attributes are required by the FDA for a compliant submission [2,3]. The vast amount of data required for each UDI submission places a significant demand on manufacturers’ data management processes. High costs for generating large numbers of UDI submissions and dangerous risks of noncompliance leaves manufacturers striving to submit perfect UDI submissions. An erroneous submission must be corrected within seven days or else it will be classified as noncompliant . To reduce errors and optimize submission compliance, manufacturers should refer to the guidance document issued by the FDA for utilizing the GUDID .
When starting to generate UDIs for their devices, there are a few UDI requirements that manufacturers must bear in mind. First of all, the identifying data for each device must be provided both as plain-text and encoded using Automatic Identification Data Capture (AIDC) technology (i.e. linear, or two-dimensional bar codes, RIFD tags, etc.) . A UDI is composed of two parts: device identifier (DI) and product identifier (PI). One can think of the UDI as an equation: UDI = DI + PI . The DI “is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device” . A PI is a conditional component of the UDI; it is required when a device label includes a lot/batch number, serial number, manufacturing date, expiration date, or is for a human, cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, the distinct identification code required by 21 CFR 1271.290(c) . If the device label includes this information, the PI conveys this information within the UDI. It is important to note that all UDIs must be issued by an FDA-accredited issuing agency. The FDA has released guidelines for receiving accreditation, but to date there are only three accredited issuing agencies: GS1, HIBBC, and ICCBBA .
The most recent UDI regulations the FDA has addressed are those concerning direct marking of devices. In June 2015, the FDA released a Unique Device Identification: Direct Marketing of Devices draft guidance. Direct marking in the realm of UDI regulations is permanently marking a UDI on the device itself. Devices that are required to have a UDI on the device label, are intended to be used more than once, and intended to be reprocessed before each use are required to have a direct marking . All device classes must satisfy this requirement, except class I devices that have a Universal Product Code (UPC) on their label and device packages. These devices require direct marking because their intended uses indicate that they will be separated from their original labels and packages. Direct marking will assure the devices are still identifiable after several uses, allowing for proper post-market surveillance activities. The UDI direct marking requirements have different compliance dates than those specified for the UDI final rule, with the first UDI direct marking compliance date being September 24, 2015 .
All of the UDI requirements, from GUDID to direct marking, will require manufacturers to invest a significant amount of time and money into achieving compliance. Facing such a daunting task, it is easy to lose sight of the benefits of the UDI system. The FDA outlines six benefits of the UDI system that it wants to accomplish: 1) More accurate reporting, reviewing, and analysis of adverse event reports so devices can be identified and corrected more quickly. 2) Fewer medical errors by allowing health care professionals to quickly and accurately identify devices and obtain important device information. 3) Enhance analysis of devices on the market with a standard, clear way to document device use. Also, a stronger post-market surveillance system can be utilized to support pre-market approval or clearance of new devices and new uses of currently marketed devices. 4) A standardized identifier will allow manufacturers, distributors, and healthcare facilities to more effectively manage device recalls. 5) Help to address counterfeiting and alteration and prepare for medical emergencies by providing the foundation for a global, secure distribution chain. 6) Lead the development of a medical device identification system that is recognized around the world .
As compliance deadlines for the UDI final rule and direct marking approach, manufacturers must begin the process of producing UDI compliant devices and packaging. Failure to do so will prevent them from selling their devices within the US, and thereby giving their compliant competitors a significant market advantage. Once all devices are UDI compliant, the FDA will be able to fully realize the benefits of this system by identifying product problems more quickly, targeting product recalls with greater accuracy, and improving patient safety.
- Mohammed, Y. UDI: What You Need to Know About Timelines, Compliance and Submissions. Med Tech Intelligence. 2014. Available from: https://www.medtechintelligence.com/feature_article/udi-what-you-need-to-know-about-timelines-compliance-and-submissions/.
- UDI: Complexities of Compliance. PTC. 2013. Available from: http://www.ptc.com/File%20Library/Topics/Unique%20Device%20Identification/The_Regulatory_Reality_PTC_UDI_ebook.pdf.
- HIBCC Guideline: Understanding FDA’s UDI Requirement. HBICC. 2013. Available from: http://www.hibcc.org/wp-content/uploads/2013/10/HIBCC-UDI-GuidelineFinalReg3.pdf.
- Global Unique Device Identification Database (GUDID), FDA, Editor. 2014.
- UDI Issuing Agencies. FDA. 2015. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIIssuingAgencies/ucm20038748.htm.
- Unique Device Identification: Direct Marking of Devices – Draft Guidance for Industry and Food and Drug Administration Staff. 2015, FDA.
- Benefits of a UDI System. FDA. 2015. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevice