FDA Issues Draft Guidance to Clarify UDI Form, Content

New draft guidance issued by FDA provides information to help labelers and issuing agencies ensure unique device identifiers contain the right information and present it in the right format.

Qmed Staff

There has been much uncertainty as the medical device industry shifts to FDA's Unique Device Identification rule, and today the agency released draft guidance intended to clear the air regarding two aspects of the rule: the form and content of the Unique Device Identifier. 

According to the original rule, which seeks to ensure every medical device has a unique identifier enabling it to be tracked from its manufacturer to its users, UDI information must be presented on device labels and packaging in both easily readable plain text and in a format that facilitates automatic identification and data capture (AIDC). The draft guidance put out today provided more detail as to what each of those formats should look like.

The plain-text version of the UDI, according to the draft guidance, must include both a device identifier and production identifiers, as well as data delimiters, which identify the different elements within the UDI. Characters used in the plain-text version of the UDI are limited to those identified in the ISO/IEC 646 standards. And although the plain-text version may be displayed in a single line or multiple lines of text, it must appear near the AIDC form of the UDI. 

The draft guidance also clarifies that the AIDC text should be able to be read by barcode scanner or some other AIDC technology and recommends that labelers test that the UDI can be reliably read at the point of scanning when such technology is used. If space limitations require it, the AIDC version may be separated into multiple segments (e.g., one for the device identifier and one for the production identifiers), but the device identifier must come first.   

Industry will have 60 days to comment on the draft guidance.  

[Image courtesy of DIGITALART/FREEDIGITALPHOTOS.NET]