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FDA Reconsiders UDI Direct Marking Requirements For Implants

An agency official says FDA is reworking the UDI direct part marking requirements for implants and making other changes in the final unique device identification rule, due out in June.

An FDA official hinted last week that the agency may be flexible on requirements to directly mark implantable devices with unique device identifiers if the UDIs can be linked to patient electronic health records.

Jay Crowley, FDA’s senior advisor for patient safety and the lead official on the developing UDI program, provided an overview of some of FDA plans for the upcoming final UDI rule during a May 1 session at the Medical Device Conference, co-sponsored by FDA and Xavier University, in Cincinnati

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