The MPE Degree

UDI Compliance – Is Your Company Ready?

UDI Compliance – Is Your Company Ready?

Unique Device Identification (UDI) is a standardized numbering and traceability system for medical devices. According to the FDA, the objective of the UDI system is that it will facilitate rapid and accurate identification of a medical device, enable access to important information concerning the device and provide a standard and clear way to document device use in clinical information systems and registries. This should result in safer, customized patient care.

A Unique Device Identification label must contain two things, the Device Identifier and the Production Identifier. The Device Identifier (DI) is a mandatory identification that specifies the version or model of the device, whereas the Production Identifier (PI) is conditional and variable – identifying many elements including the date manufactured, lot or batch number, serial number, and expiration date. UDI appears in two forms when labeled on a device – a readable plain-text and an automatic identification and data capture (barcode).

The FDA has strict guidelines in place for utilization of UDI (known as the UDI Rule) that include mark, submit, and comply. ‘Mark’ refers to the actual labeling of the medical device using the DI and PI, ‘submit’ refers to publishing the UDI and submitting required data attributes to the Global UDI Data Base (GUDID), and ‘comply’ refers to the compliance dates for UDI requirements.

In order to be considered UDI Compliant, you must meet the specified requirements, in place by the FDA, by the appropriate compliance date. These compliance dates span over seven years after initial use of the unique device identifier. Phasing the UDI rule over several years ensures proper implementation.

For more details on UDI compliance, visit: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

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