FDA: Guidance on UDI Marking Finalized

The draft guidance has been finalized, addressing direct marking, compliance dates, UDI formats, reprocessing and exceptions to direct marking.

Last month, the FDA finalized its guidance "Unique Device Identification: Direct Marking of Devices." As the agency reports, the document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements.

The draft guidance was published in June 2015, and published final guidance after considering public comments and questions.

According to the FDA, “If a UDI is required on a device label, the device must have a UDI permanently affixed to the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. This requirement applies to all device classes, except class I devices that bear a Universal Product Code (UPC) on their label and device packages, as provided in 21 CFR 801.40(d).”

The 12-page guidance addresses direct marking, compliance dates, UDI formats, reprocessing and exceptions to direct marking, as well as interpretations for “intended to be used more than once” and “intended to be reprocessed.” 

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