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The draft guidance has been finalized, addressing direct marking, compliance dates, UDI formats, reprocessing and exceptions to direct marking.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

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Break out of the ordinary: see what’s new in life sciences packaging