THIS PAGE HAS BEEN FORMATTED FOR EASY PRINTING

February 2009 Regulatory Affairs Monthly Topic

FDA Working to Devise Unique Identifier System for Devices

The requirement that individual medical devices be followed throughout the product lifecycle is attracting attention from both the U.S. Food and Drug Administration (“FDA”) and device industry stakeholders.  As part of the FDA Amendments Act of 2007 (“FDAAA”), FDA was granted authority to implement regulations requiring medical devices to display a unique identifier.  This authority was comparable to existing FDA regulations that require unique identifiers on drug and biologic products.  Devices were not part of the 2004 regulation that imposed these requirements, reflecting in part that devices lacked a standard national coding system comparable to the bar code that has been established for drugs.(1)(2)  While FDAAA does not mandate a specific type of device identifier, it does specify that a unique device identifier (“UDI”) must be placed on the device label, unless an alternative location is specified, or unless FDA has exempted the device or group of devices from the UDI system.(3)  The UDI must adequately identify the device throughout its distribution and use, and may need to include information such as the lot or serial number, if required by FDA. 

FDAAA’s UDI requirements came in response to pressure from Congress and other stakeholders, who had long advocated a universal UDI system.(4)  These supporters argue that unique identifiers enhance patient safety and reduce medical errors, and maintain that UDIs could improve device recalls, adverse event reporting, and post-marketing surveillance.(5)  Opponents, however, have consistently expressed concern that mandatory UDIs will increase costs without evidence of enhanced safety.(6)

While moving toward widespread use of unique device identifiers is a somewhat recent development, FDA has long had the authority to order manufacturers to track certain types of devices throughout their life cycle and use.(7)  Under this authority, FDA has required firms to track a number of higher risk devices, including prosthetic heart valves, silicone breast implants, and implantable infusion pumps.(8)  However, because FDA has not mandated a specific tracking method, manufacturers have had the freedom to select a tracking method on a product by product basis.(9)  These tracking methods have included such innovative approaches as radiofrequency tags, which are one of the types of UDIs currently under consideration for FDA’s UDI system.(10)

Apart from FDA’s requirements, many hospitals and health systems have adopted internal policies that require device manufacturers that contract with the hospitals to provide unique identifiers on their products.(11)  As a result, some medical device firms already have adopted international supply chain standards promulgated by global standards organizations such as GS1 and the Health Industry Business Communications Council, which require the use of unique numbers or bar codes to identify devices and their location throughout packaging and use.(12)
 
FDAAA directs FDA to implement the UDI program through the formal rulemaking process.  As part of this process, FDA held a public workshop on February 12, 2009, to explore UDI issues.  At the workshop, FDA outlined the key steps in creating the UDI system:  1. developing standardized UDIs; 2. determining placement and technology of UDIs; 3. creation and maintenance of a UDI database; and 4. implementation/adoption of UDIs by relevant stakeholders.(13)  Additionally, FDA sought industry input regarding what information to include in a UDI, which devices to exempt from the requirement, and how to address reprocessed, single-use devices.(14)  Industry representatives urged the agency to initially focus on higher–risk devices, suggesting that UDI solutions and requirements should vary according to the type of product.

FDA intends to issue a proposed rule on the UDI system by the end of 2009.  Interested parties can submit written comments at www.regulations.gov until February 27, 2009.  More information regarding the workshop is available at http://www.fda.gov/cdrh/meetings/021209workshop/.

Copyright © 2011 CIMIT. All rights reserved.