FDA Medical Device Regulation Update: FDA Issues Final Rule for Unique Device Identification System

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On September 20, 2013, the U.S. Food and Drug Administration (“FDA”) announced the issuance of the final rule for the Unique Device Identification System (“UDI System”). The final rule sets forth the labeling and reporting criteria for medical devices, combination products that contain devices, and devices licensed under the Public Health Service (“PHS”) Act. In its press announcement, the FDA explained that the UDI System was developed to help “identify product problems more quickly, better target recalls, and improve patient safety.” (For additional coverage of the FDA’s final rule for the UDI System, please read Reuters’ article here and Bloomberg BNA’s article here.)

The medical device industry has anxiously awaited the FDA’s final rule for the UDI System since 2007, when President Bush signed the Food and Drug Administration Amendments Act (“FDAAA”). Despite pressure from industry and lawmakers, the FDA failed to release a final rule in a timely fashion. In 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (“FDASIA”), which imposed on the FDA mandatory publication deadlines. Thereafter, on July 10, 2012, the FDA issued a proposed rule for the UDI System.

UDI System Requirements

The UDI System requires certain medical devices to bear a UDI on the device’s package and label. The UDI System is comprised of two main parts: 1) the device identifier (“DI”) and 2) the production identifier (“PI”). The DI is a mandatory, fixed portion of the UDI that identifies the labeler and the specific version of a model of a device. The PI is a conditional or variable portion of the UDI that identifies one or more of the following when included on the label of a device: the lot or batch number of the device, the serial number of a device, the expiration date of a device, the device’s manufacturing date, and if the product is a human cell, tissue, or cellular and tissue-based product (“HCT/P”) regulated as a device, a distinct identification code.

The final rule articulates target dates by which medical devices are expected to comply with the applicable UDI regulations. These compliance dates come into effect as early as 2014 and as late as 2020. Within one year of the publication of the final rule for the UDI System, all class III medical devices and devices licensed under the PHS Act must bear a UDI. Class II medical devices are expected to bear a compliant UDI within three years of the publication of the final rule, and all class I, II, and III medical devices must bear a UDI within five years of the publication of the final rule. Within seven years of the publication of the final rule, all Class I devices and devices that have not been classified into any class are required to bear a UDI as a permanent marking on the device if the device is intended to be used more than once and intended to be reprocessed before each use. (For a more detailed explanation of the FDA’s compliance dates, please click here.)

Global Unique Device Identification Database

In addition to specific requirements for UDI labeling, the FDA will also require medical device manufacturers to submit information about the devices to the FDA. Together with the final rule for UDI labeling, the FDA released the Draft Guidance for the Global Unique Device Identification Database (“GUDID”). The GUDID is a new database that will serve as a “repository of key device identification information.” The draft guidance explains that manufacturers of medical devices are required to submit information about the labeler and the device model to the FDA, which will be entered into and publicly searchable through the GUDID. Production Identifier information, on the other hand, does not need to be submitted to or stored in the GUDID. The FDA is currently accepting public comments on the draft guidance and recommends submitting a comment for consideration before November 25, 2013.

The FDA’s staggered timeline for compliance with the new UDI System provides industry with considerable time to modify their device labeling and reporting operations in accordance with the new regulations. Consumers and advocates for the UDI requirements, however, seem dismayed by the lengthy implementation timeline. In addition to the six years it took the FDA to finalize the UDI regulations, consumers will have to wait another seven years for the UDI medical device tracking system to be fully functional and operational.