A UDI is a unique code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center.
The FDA proposes 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.
This proposal was introduced in response to requirements in the recently passed Food and Drug Administration Safety and Innovation Act.
More Articles on Device Safety:
Congress Passes FDA Safety and Innovation Act With Drug Shortage Provisions
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Consumers Union Urges Congress to Strengthen Medical Device Safety
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