In commenting on the proposed rule to establish a unique device identifier for medical devices, provider alliance Premier Inc. calls for slashing the seven-year implementation timetable.
All classes of devices should have a UDI on the label or package in two years, and direct markings on the devices in three years, Premier contends. The recently enacted FDA Safety and Innovation Act clearly demonstrates congressional interest for quick UDI implementation, it adds. “UDI is the missing link to protect patient safety. Enabling health care providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting.”
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