FDA Home Page | CDRH Home Page | Search | A-Z Index

FDA > CDRH > Unique Device Identificaton

Unique Device Identification

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.  Comments due February 27, 2009. (NOTE: The registration link in the Federal Register notice is incorrect. Registration details are available here.)

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

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.

Related Documents

• FDA Unique Device Identification Public Workshop: February 12, 2009
• Information about the October 25, 2006 public meeting on Unique Device Identification
• August 9, 2006 Public Notice that requested comments on Unique Device Identification
• Comments Received from the August 9, 2006 Public Notice on Unique Device Identification
• Presentations
• ERG Final Report: Unique Identification for Medical Devices (March 22, 2006)
• The Food and Drug Law Institute / CDRH Report on Meeting to Discuss Unique Device Identification (April 14-15, 2005)
• ECRI / FDA White Paper: Automatic Identification of Medical Devices (August 17, 2005)
• The Food and Drug Law Institute / CDRH Report on Meeting to Discuss Unique Device Identification (October 27, 2005)

Contact Us

For further information contact:
Jay Crowley
Center for Devices and Radiological Health (HFZ–500)
Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850
Phone: 240–276–3400
e-mail: CDRHUDI@fda.hhs.gov

Updated February 23, 2009

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH