FDA recently conducted pilot activities to explore opportunities and challenges in implementing a Unique Device Identifier Database and to assess the feasibility of FDA's internal processes to incorporate UDI information.

Results of FDA Pilot Activities To Explore Opportunities and Challenges With the Implementation of a Unique Device Identifier System

The UDI Team is collecting Use Cases - stories addressing common concerns / questions with UDI implementation. Click the link below for more information!

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On September 27, 2007, President George W. Bush signed into law FDAAA (Public Law 110-85). Section 226 of FDAAA amended the Federal Food, Drug, and Cosmetic Act (the act) by requiring the establishment of a UDI system. Specifically, section 226(a) of FDAAA created a new section 519(f) of the act (21 U.S.C. 360i(f)) stating that:

"The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number."

A UDI system will provide for early detection of defective devices and will facilitate device recalls to ultimately enhance patient safety and reduce medical errors.

FDAAA directs FDA to implement the UDI system through the formal rulemaking process. As part of this process, FDA held a public workshop on February 12, 2009 where the following was discussed:

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.

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.

FDA intends to issue a proposed rule on the UDI system by the end of 2011 with the Final Rule slated to be released in 2012.

For more information on the FDA UDI, please click here or copy and paste the entire URL below:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
UniqueDeviceIdentification/default.htm