The FDA published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed. The rule was established to improve the quality of information in medical device adverse events reports and assist the FDA in determining issues with medical devices as they arise. Now that the rule has been set, medical device manufacturers need to ensure they understand the rule so they can properly comply with the regulation.
To meet the UDI regulations set by the FDA, you must first understand the two main aspects of the rule. To start, a unique number is assigned by the device manufacturer to the version or model of a device, called a unique device identifier. The purpose of this number is to identify production-specific information including the product’s lot number, expiration date, and manufacturing date. Next, the FDA plans to create a publicly searchable database, called the Global Unique Device Identification Database that will serve as a reference catalogue for every device. This will allow anyone to search a specific device and understand its background and history.
Now you may be asking yourself what exactly needs a UDI label, and the answer is pretty simple: all Class I, II, and III medical devices. This means every individual Class II and III medical device, as well as the device packaging and all base packaging. For Class I devices, all packaging must bear a UDI label. The manufacturer must create and maintain the UDI from an FDA accredited issuing agency. The label must have unambiguous dates, and data must appear in both plain text format and a format that can be scanned by some AIDC technology. Every device identifier must include brand name, model number, size of version or model, production identifiers, FDA product code, GMDN term, FDA listing number and the number of individual devices in each package. In addition, label substrates must meet specific durability requirements established under IEC 60601-1, 3rd Edition and possibly under UL 969. The compliance dates for implementation have been set by the FDA depending on the class of the device, but there are some exceptions outlined in the FDA rule (PDF).
The FDA created the UDI rule with the expectation that the benefits to the general public and the medical community will be appreciated for years to come. The rule will enhance the ability to quickly and efficiently identify marked devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems. The rule provides a consistent and clear way to identify medical devices.
Now that the rule has been established and all the guidelines have been laid out, medical device manufacturers need to ensure they are meeting the regulations in an effective manner. The regulation set by the FDA is not meant to be overwhelming, but rather provide a safe way to regulate medical device labels and establish a system to ensure patient safety. Device manufacturers should be auditing their internal processes and capacity for managing device data in order to incorporate the data required by the UDI rule. Data may be managed in-house or through an outside data management service. Device manufacturers should also be reviewing their materials buys to confirm that label substrates being used meet all durability requirements.
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