FDA Finalizes 2015 Draft Guidance on UDI Marking Requirements

Posted 16 November 2017 | By Zachary Brennan

FDA Finalizes 2015 Draft Guidance on UDI Marking Requirements

The US Food and Drug Administration (FDA) on Thursday finalized guidance first released in 2015 to clarify when direct marking of devices with a unique device identifier (UDI) is required.

FDA requires a device to be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use.

The guidance provides FDA's interpretation of the terms, "intended to be used more than once" and "intended to be reprocessed," clarifies when direct marking of devices with a UDI is required, provides recommendations for how labelers should comply with the direct marking requirements and clarifies the criteria for exceptions to the direct marking requirement.

FDA said in a Federal Register notice on Thursday that it “considered the comments received on the draft guidance, including comments responding to the specific questions in the notice of availability, and revised the guidance as appropriate in response to these comments.

Final Guidance


Tags: data, Integrity

Categories: Regulatory News

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