FDA Unique Device Identification; Request for Comments

August 11, 2006

FDA Unique Device Identification; Request for Comments

SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to request comments to help the agency understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. We are also interested in understanding the issues associated with the use of various automatic identification technologies (e.g., bar code, radiofrequency identification). We invite comments about specific UDI issues for medical devices.

DATES: Submit written or electronic comments by November 9, 2006.

ADDRESSES: Submit written comments concerning this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: David Racine or Jay Crowley, Center for Devices and Radiological Health (HFZ-500), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3400, e-mail: CDRHUDI@fda.hhs.gov.

Read the entire Federal Register notice via the related link below...