The article offers a synopsis of the US Food and Drug Administration (FDA) final ruling on Unique Device Identification (UDI). It also calls out on how the decision might impact the medical device industry and the steps to be taken by businesses to gain compliance with the FDA Mandate.
In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies. As UDI is soon expected to be a reality in the US and Europe, here is a quick overview on how UDI can help improve patient safety and help device manufacturers minimize risk and make product recalls much easier to contain.
