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www.fdanews.com/articles/61727-fda-seeks-comments-on-possible-benefits-drawbacks-of-udi-system

FDA SEEKS COMMENTS ON POSSIBLE BENEFITS, DRAWBACKS OF UDI SYSTEM

August 15, 2006

The FDA is seeking comments on how a unique identification system for devices might reduce medical errors, facilitate recalls and improve adverse event reporting.

The agency wants perspective about the possible benefits and costs of developing a unique device identification (UDI) system. It also wants to know how such a system might integrate automatic identification technologies such as bar codes and radio frequency.

In February 2004, the agency published a rule requiring bar codes on certain human drug and biological products; it did not apply to devices. The agency reasoned that, "unlike drugs, medical devices do not have a standardized, unique identifying system comparable to the NDC [National Drug Code] number" -- which identifies the labeler, product and package -- and that the absence of such a system "complicates efforts to put bar codes on medical devices."

In issuing this request for comments, the FDA is responding to calls by Congress and a consortium of hospital groups asking it to revisit the issue in the interest of patient safety.

(http://www.fdanews.com/ddl/33_32/)