U.S. FDA issues final rule on medical device identifier codes – Reuters – 20 September 2013

Posted on September 24, 2013. Filed under: Health Technology Assessment | Tags: , , , |

U.S. FDA issues final rule on medical device identifier codes – Reuters – 20 September 2013

“The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls.

The codes, known as unique device identifiers, or UDIs, will be entered into a database that the agency will maintain as a publicly searchable reference catalogue.

… continues on the site

(Reporting by Toni Clarke in Washington; Editing by John Wallace, David Gregorio and Sofina Mirza-Reid)”

FDA Rule

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