December 05, 2013 Articles

Medical Device Tracking: The FDA's New Unique Device Identification System

By Kara T. Stubbs and Wynn J. Maxwell

On September 24, 2013, the Food and Drug Administration (FDA) published its final rule regarding a tracking system for the vast majority of medical devices. After almost a decade and a half of wrangling, the FDA's unique device identification system project has finally come to fruition. Designed to reduce medical error, enhance analysis of medical devices, and allow for easier identification of problem devices, the unique device identification system has been hailed as a major step forward in the areas of patient safety, modernization of post-market surveillance, and the facilitation of medical technological innovation.

The Unique Device Identification System
The unique device identification system is made up of two major components. First, each qualifying product is required to have a unique device identifier (UDI), a numeric or alphanumeric code that distinguishes each individual product. The UDI contains a unique tracking number known as a device identifier (DI), similar to a stock keeping unit (SKU). The UDI may also contain a product identifier (PI), a variable code that reflects information normally on the device's label. The information conveyed by a PI may include the product's batch/lot number, any expiration dates, the manufacturing date, the serial number, and the section 1271.290(c) code required for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

The second part of the unique device identification system is a publicly accessible database to track all products with UDIs, known as the Global Unique Device Identification Database (GUDID). While GUDID is intended to be a comprehensive database, it will not contain identifying personal patient information for any device with a UDI. Press Release, Food & Drug Admin., FDA Finalizes New System to Identify Medical Devices (Sept. 20, 2013).

Compliance with the Final Rule
Like many large government projects, the unique device identification system will be implemented in stages. As the final rule was published on September 24, 2013, all subsequent deadlines are based on that date. Each stage is designed to be a step toward the ultimate goal of permanently marked UDIs on every applicable medical device, coupled with a complete GUDID.

The first stage ends one year after publication of the rule and primarily concerns Class III medical devices. By September 24, 2014, all Class III medical devices and devices licensed under the Public Health Service Act must have a UDI on the label and packaging. The second stage ends two years after publication of the rule and primarily concerns implantable, life-sustaining, or life-supporting devices. By September 24, 2015, the labels and packaging of all such devices must contain a UDI. However, if any implantable, life-sustaining, or life-supporting devices are intended for multiple uses and are intended to be reprocessed between uses, the UDI must be permanently marked on the device itself. (The FDA publishes a list of devices it classifies as implantable, life-sustaining, or life-saving.)

The third stage ends three years after publication of the rule and primarily concerns Class II medical devices. By September 24, 2016, all Class II medical devices must have a UDI on the label and packaging. In addition, all Class III medical devices must have their UDIs permanently marked on the device itself. The fourth stage ends five years after publication of the rule and primarily concerns Class I medical devices. By September 24, 2018, all Class I medical devices and all devices not classified as Class I, II, or III that fall under the rule must have a UDI on the label and packaging. In addition, all Class II medical devices must have their UDIs permanently marked on the device itself. Finally, the fifth stage ends seven years after publication of the rule. By September 24, 2020, all Class I medical devices and all devices not classified as Class I, II, or III that fall under the rule must have their UDIs permanently marked on the device itself.

As for the second part of the unique device identification system, all data for devices requiring UDIs must be submitted to the GUDID by the same date that a given product's label and packaging must bear a UDI. For instance, all Class III medical device data must be submitted to the GUDID by September 24, 2014, and all Class II medical device data must be submitted by September 24, 2016. (For further discussion of compliance dates, see Food & Drug Admin., Unique Device Identification (UDI), UDI Rule and GUDID Guidance.)

Failure to comply with these deadlines will not be taken lightly. Any failure to meet a compliance date will result in the device being considered "misbranded" under 21 U.S.C. § 352(t). This is a prohibited act under 21 U.S.C. § 331(q)(1)(B), and subsequent enforcement actions can include seizure, injunction, and criminal and civil penalties.

Concerns
Despite the numerous positive anticipated consequences of the entire unique device identification system, there are still snags and concerns that have arisen. Under the new rule, all dates must be presented in the same format: month, day, year. The month must be shown as a capitalized three-letter abbreviation (i.e., JAN or FEB), while the day and year must be shown numerically. Manufacturers of products that traditionally have expiration dates have expressed concern over the new date-labeling scheme for one simple reason—many expiration dates specify a month, not an individual day. Because the final rule requires all dates to be formatted identically, manufacturers of products that are normally listed with only an expiry month have raised concerns about how to label their products according to their own information yet still remain in compliance with the unique device identification rule. For the full text of the rule, see Final Rule, Unique Device Identification System, 78 Fed. Reg. 58,786 (Sept. 24, 2013) .

Another concern some have raised is the added cost to manufacturers. Given the ongoing nature of the labeling requirement, this is not a one-time expenditure. The FDA had considered both a high-cost option (all devices must have a PI) and a low-cost option (all products only need be labeled with a DI) before settling on the current compromise. Even so, the rule is projected to cost the domestic industry over $350 million in one-time costs, as well as over $55 million in annual recurring costs. While the costs to the public would remain relatively low (estimated at less than $200,000 a year for governmental entities), the expense is still a concern to some. (For a full economic analysis of the rule, see Eastern Research Group, Unique Device Identification (UDI) for Medical Devices: Economic Analysis of the Final Rule (July 11, 2013)).

The Unique Device Identification Rule Moving Forward
Regardless of concerns or worries, the unique device identification rule will be changing the world of medical devices and medical device law. It remains to be seen where this impact will be felt the strongest, but the possibilities are everywhere. The FDA and the public now have a method of tracking and monitoring failure rates for a given device. On the flip side of that coin, manufacturers now have a tool to analyze success rates. Ultimately, the rule will provide a deluge of never-before-seen information, and what people will do with that information is yet to be seen.

Keywords: litigation, products liability, UDI, unique device identification, FDA, GUDID, tracking, medical devices


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