(FDA: Washington, D.C.) -- In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.

A UDI system has the potential to improve the quality of information in medical device adverse-events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community, and patient and consumer groups, and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

“The safety of medical devices is a top priority for the FDA, Congress, industry, and patients,” says FDA Commissioner Margaret A. Hamburg, M.D. “The unique identification system will enhance the flow of information about medical devices, especially adverse events, and as a result will advance our ability to improve patient safety.”

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