FDA Drafts Guide on Medical Device Tracking

The Food and Drug Administration recently released guidelines for identification tags that will track medical devices from manufacturers to users.

The draft aims to define the expected content and forms of the Unique Device Identifier (UDI). The agency is phasing in requirements for UDIs in order to better track medical devices. A UDI includes the device’s specific model information and data for up to five product elements, such as expiration data or serial number.

The guidance notes the UDI is required in two formats: a plain-text version and an automated version that can be added to a patient’s electronic health record (HER).

The draft also clarifies how information on the UDI should be ordered and presented, requiring the automated market be in a format capable of being read by a barcode scanner.

The FDA is currently accepting comment on the guidance.

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