US FDA: Definitief richtsnoer voor UDI-markering

The FDA has finalized its guidance "Unique Device Identification: Direct Marking of Devices." 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 was published in June 2015, and published as final guidance after considering public comments and questions.
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” (Serializationcountdown, 29 december 2017).
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