12/4/2013

The FDA has issued an update on its final rule to set up a Unique Device Identification system for medical devices. Companies with U.S. marketing approval must use a global UDI database administered by the FDA when submitting device identification data, and they have two options for doing so, as discussed in draft technical details released by the agency. Companies may work with a Web interface or submit electronically using an HL7 SPL file.

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