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Unique Device Identification--FDA Update

by Barbara Kram, Editor | October 16, 2006
FDA is announcing a public meeting and vendor display to discuss the issues associated with the development, implementation, and use of a unique device identification system and the use of various automatic identification technologies. Complete information about the meeting can be found in the Federal Register announcement. The meeting will be held on Wednesday, October 25, 2006 from 9 a.m. to 4 p.m. at:

Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878
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For full information and links go to http://www.fda.gov/cdrh/ocd/udi/

The public meeting is being held at the Washingtonian Marriott in Gaithersburg, Maryland. We have a few rooms being held at the meeting hotel. Below is a list of hotels within easy walking distance of the Washingtonian Marriott.
Washingtonian Marriott (meeting hotel)
9751 Washingtonian Boulevard
Gaithersburg, Maryland 20878 USA
Phone: 301-590-0044

Courtyard Gaithersburg Washingtonian Center
204 Boardwalk Place
Gaithersburg, Maryland 20878 USA
Phone: 301-527-9000
Residence Inn Gaithersburg Washingtonian Center
9721 Washingtonian Blvd.
Gaithersburg, Maryland 20878 USA
Phone: 301-590-3003

SpringHill Suites Gaithersburg
9715 Washingtonian Blvd.
Gaithersburg, Maryland 20878 USA
Phone: 301-987-0900

On August 9th, 2006, FDA issued a press release drawing attention to a Federal Register Notice, published on August 11, 2006, requesting comments to help the agency understand how the use of a Unique Device Identification (UDI) system may improve patient safety, for example, by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting.

Comments can be submitted in writing to:
Division of Dockets Management (HFA305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

Electronic comments can be submitted to http://www.fda.gov/dockets/ecomments

Please identify all comments with Docket No. 2006N-0292

For further information contact:
David Racine or Jay Crowley
Center for Devices and Radiological Health (HFZ500)
Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850
Phone: 2402763400
e-mail: CDRHUDI(at)fda.hhs.gov

The Federal Register Notice references these 4 reports:

* 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)

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