The US Food and Drug Administration is convening a public workshop on February 12, 2009 to obtain input from stakeholders regarding the development of a unique identification system for medical devices. Such a system is expected to facilitate device recalls and also may provide an opportunity for detecting early warning signs of a defective device.  Potential technology options applicable to a unique device identification (UDI) system include bar codes and radiofrequency identifiers.

FDA has been investigating the use of unique identifiers on medical device labels for several years, a process that included commissioning a report on a potential UDI system.  More recently, the FDA Amendments Act of 2007 mandated the development of such a system without including a firm deadline. The Act requires the unique identifier to “adequately identify the device through distribution and use.” Following the February workshop, FDA plans to begin drafting regulations to implement the requirements of the Act.

The agency has identified a significant number of questions for which it seeks input through the workshop.  Under the specific language of the FDA Amendments Act, FDA has discretion either to require the unique identifier to be located on the device label or to designate an “alternative placement.” The agency also has discretion to exempt particular devices or classes of devices, as well as whether to require a lot or serial number to be included as part of the identifier. As a consequence, those issues are well represented in the questions listed in the workshop announcement:

1.  What types of devices or particular devices should be subject to the requirements of a UDI system? Which types of devices or particular devices should be excepted?

2.  What are the characteristics or aspects necessary to uniquely identify a device?

3.  What should be the UDI’s components? (e.g., should the lot or serial number be required?)

4.  Where should the UDI be placed? What should be the criteria for alternative placement of the UDI?

5.  How should the UDI be presented? (i.e., what automatic identification technology would be appropriate?) Should FDA mandate a particular technology or permit different standards to be used depending on the type of device?

6.  How should the UDI Database be developed and maintained?

7.  What is the magnitude of the problem to be addressed by the establishment of a UDI system? The FDA asks specific questions on this issue of manufacturers and of hospitals and other healthcare entities. For example, the Agency would like to obtain information about manufacturers’ current practices and the potential impact of adding a UDI as part of their production operations. 

Each question is further elaborated upon in the workshop announcement. Moreover, in addition to receiving comments on its specific questions, FDA is interested in gaining insight on the different identification technologies that are currently available. The Agency invites manufacturers and distributors of automatic identification technologies to attend the workshop to display and demonstrate their technology.

Members of the public are encouraged to participate in the workshop and can register electronically here (where an agenda for the meeting also will be available). The FDA’s workshop announcement can be found here.

If you have any questions about unique identifiers for medical devices, please do not hesitate to contact one of the following Arent Fox attorneys:

James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

Brian P. Waldman
waldman.brian@arentfox.com
202.857.8971

Wayne H. Matelski
matelski.wayne@arentfox.com
202.857.6340

Joanne S. Hawana
hawana.joanne@arentfox.com
202.715.8591