In a Federal Register Notice (FRN) published on July 26, 2016 the Food and Drug Administration (FDA) released a draft guidance to the industry titled, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”

The UDI system was established on September 24, 2013 and through distribution and use, identifies the devices that are being distributed throughout the United States. To assist in this identification it is required that all medical devices bear a UDI label on every device package, unless exempted. This draft guidance, “describes the two forms of a UDI and clarify the content of the UDI, including the data delimiters that identify specific data elements within the UDI.”

Comments for the FDA Draft Guidance should be submitted by September 26, 2016. Copies of the draft guidance can be obtained on the FDA website, under the Center for Devices and Radiological Health.

The full notice can be accessed here