FDA Issues Guidance on UDI Direct Marking Requirements for Medical Devices
The Food and Drug Administration on Nov. 17 issued a new guidance document on direct marking requirements for medical devices. The new guidance includes information on when direct placement of unique device identifiers is required, what devices require direct marking…
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and what methods are acceptable. The guidance document also discusses the effect of adding direct marking on device submissions to FDA and user fee requirements. Under a final rule issued in 2013 (see 13092020), direct marking of UDIs onto devices, as opposed to on labels and packaging, is required for devices intended for more than one use that must be reprocessed between uses.