2015 Draft Guidance on UDI Marking Requirements finalised by FDA

Draft guidance, which was first released in 2015, has been finalised by the US Food and Drug Administration (FDA) to clarify when direct marking of devices with a unique device identifier (UDI) is required.

The UDI system makes it possible to rapidly and definitively identify a device, along with key qualities that affect its safe and effective use. The aim is to facilitate greater accuracy when reporting adverse events by making it easier to identify the devise at fault in the submitted report.

Under 21 CFR 801.45, “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”

The finalised guidance explains the terms “intended to be used more than once” and “intended to be reprocessed”, provides instructions for how labellers should adhere to the direct marking requirements and confirms the criteria for exceptions to the direct marking requirement.

The FDA has revised the guidance in response to comments received on the draft guidance, which includes opinions that respond to specific questions in the notice of availability.

The release of the finalised guidance is in line with the FDA has issuing an extension to the unique device identifier (UDI) compliance deadline for class I devices, after a number of the technological and policy challenges were identified with the class II and III devices. The agency is also delayed the direct mark requirement for Class I and unclassified devices, which requires devices to bear a UDI on the device itself if the device is reusable and must be reprocessed before each use, from September 2020 to September 2022.

To read the final guidance document, please click here.