Reuters: U.S. FDA Issues Final Rule on Medical Device Identifier Codes

Publication: Reuters

Author: Toni Clarke

09/20/2013 - "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."


"Josh Rising, director of the Pew Charitable Trusts' medical devices initiative, said the new rule will help improve safety, but added it is just the first step.

"To fully realize the new system's benefits, hospitals, health plans and physicians must integrate these codes into patients' health records and insurance billing transactions," he said."

Read the full article at Reuters.


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