Nonprofit medical standards group GS1 US has updated its implementation guideline, “Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI).” The updated version (R2.0) now reflects new language and context of the U.S. Food and Drug Administration’s (FDA) regulation since the first implementation guideline was published in 2014.

Since passing the rule in 2013, the FDA has issued numerous updates and clarifications including FDA draft guidance, final guidance, and extensions or modifications to certain aspects of the rule. The updated implementation guideline includes instructions for using GS1 Standards for some UDI requirements including:

  • Device identifier – GS1 Global Trade Item Number (GTIN)
  • Production identifiers (PIs) – GS1 Application Identifiers (AIs)
  • UDI representation – GS1 barcodes, human readable text
  • Direct device marking – GS1 permanently marked item rules
  • Global Unique Device Identification Database (GUDID) submission – GS1 Global Data Synchronization Network (GDSN)

  •  

    PHOTO COURTESY OF SIMTEC

    ISO Class 8 clean room addition

    Simtec Silicone Parts, a U.S.-based provider of liquid silicone rubber (LSR) and LSR multi-shot injection molding, has added a Class 8 clean room. Material staging and tool change occur outside the clean room; parts from fully automated 1-shot and 2-shot lines are robotically removed and transported within a controlled enclosure for delivery to the clean room for inspection, post-curing, and bagging. The design and infrastructure enable quick expansion and growth as needed.