Unique Device Identification

The FDA is holding a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple stakeholders to obtain information and comments on issues confronting the effective and efficient incorporation of UDIs into appropriate data sets, to identify barriers and incentives to their adoption and use, and to understand the best solutions and practices to resolve open issues.

• Unique Device Identification (UDI) for Postmarket Surveillance and Compliance Public Workshop, September 12-13, 2011

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On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification System. This new system when implemented will require:

• the label of a device to bear a unique identifier, unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices.
• the unique identifier to be able to identify the device through distribution and use
• the unique identifier to include the lot or serial number if specified by FDA

FDA will shortly begin developing draft regulations to implement these requirements. Interested stakeholders may wish to subscribe to Email updates for Unique Device identification to be notified as they become available.

Contact Us

For further information contact:
Jay Crowley
Center for Devices and Radiological Health 
Food and Drug Administration,
10903 New Hampshire Avenue

WO66 Room 2315
Silver Spring, MD 20993
Phone: 301-796-5700
e-mail: CDRHUDI@fda.hhs.gov