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.
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The draft guidance has been finalized, addressing direct marking, compliance dates, UDI formats, reprocessing and exceptions to direct marking.
Dec 29, 2017
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Medical Device Innovations Report
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