A UDI is a unique code that provides certain basic identifying information about a device, such as the name of the manufacturer and the type of device. This information will be made publicly available in a database, and no identifying patient information will be stored in this device information center. The FDA proposed that a UDI system could allow more accurate reporting of adverse events related to medical devices and a more consistent way of entering information about a device into health IT systems.
In its letter to the FDA, the AHA also outlined recommended changes to the proposed rule, including creation of an international standard for expiration dates on device labels, and urged the agency to roll out the system within three years.
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