The FDA’s UDI Rule is Final: What’s Next?

The U.S. Food and Drug Administration (FDA) published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD, and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed. The rule was established to improve the quality of information in medical device adverse events reports and assist the FDA in determining issues with medical devices as they arise. Now that the rule has been set, medical device manufacturers need to ensure they understand the rule so they can properly comply with the regulation.