Dive Brief:

• GS1 US has overhauled its guideline on applying its system of standards to FDA's unique device identification requirements.

• The changes, which affect most of the document, are intended to align the guideline with updates and clarifications issued by FDA since the publication of the original GS1 text in 2014.

• GS1 has also added information to help manufacturers get started with UDIs, including new subsections on assigning device identifiers and the basic questions companies need to ask for each product.

Dive Insight:

FDA passed its UDI rule in 2013. GS1, a FDA-accredited issuing agency for UDI, published its guideline to the implementation of the rule in September 2014.

Since then, FDA has continued to tweak the interpretation and implementation of the rule through guidance documents and modifications to certain aspects of the requirements. In contrast, GS1 kept its 2014 text the same, causing its position to diverge somewhat over time from the latest FDA advice.

To realign its guideline to FDA's position, GS1 has reworked its implementation guideline to create version 2.0 of the document. Almost all parts of the document feature changes.

Among the almost 20 new subsections added by GS1 are several intended to help device companies get started with UDIs. These subsections detail what manufacturers need to know before assigning a GS1 device identifier, known as a Global Trade Item Number (GTIN), to a product and explain how to determine the appropriate GTIN structure.

Other sections cover more specific points, such as how to convert the GTIN structure to a shareable format and understand the syntax used by the application identifiers encoded within GS1 barcodes.

The changes are intended to bring the implementation guideline up to date yet FDA's position is unlikely to remain static over the coming years. In the weeks since GS1 finalized its guideline, FDA has issued guidance on the use of UDIs by products that package two or more devices together for the convenience of the user. FDA still has to finalize draft guidance on the form and content of UDIs.   

The use of UDIs is changing, too. The 2020 fiscal budget features funding to include UDI in claims data, a move watchdogs argue will improve patient safety. Interest in the idea dates back to early plans to create a national medical device postmarket surveillance system around seven years ago.