Unique Device Identification

FDA recently completed a pilot test of a prototype UDI database. The purpose of the pilot was to better understand and assess the feasibility and usability of a prototype Unique Device Identifier Database (UDID). We were especially interested in manufacturer's ability to identify and organize the data and load it to the system as well as user’s ability to retrieve and export the information.

• SSS-GHX Development of the Prototype Unique Device Identifier Database: Report of a Pilot Test on Usability and Feasibility

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FDA has published a notice in the Federal Register announcing a Public Workshop on 12 February 2009 and requesting comments on a number of UDI related issues. Please see: Docket No. FDA-2008-N-0661, CDRH 200866. Unique Device Identification System; Public Workshop; Request for Comments.

• Meeting Information: FDA Unique Device Identification Public Workshop: February 12, 2009
• Comments Submitted to the Docket

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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