GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements
GS1 US recently updated its unique device identification (UDI) implementation guideline, with new instructions on device identifiers (DIs), production identifiers (PIs), human readable information (HRI) and direct marking.The implementation guideline was updated to reflect the policy changes and clarifications that FDA has issued since the guideline’s 2014 version. The updates added information on the two UDI segments, including new details on the GS1 Global Trade Item Number (GTIN) serving as a DI and new PI guidance on using application identifiers (AIs) under the GS1 system.
Details on GTIN explain the differences between assigning GTINs as UDI DIs, encoding GTINs in GS1 barcodes and sharing or storing GTINs. Guidance on selecting a GTIN structure when assigning a DI offers four considerations, which relate to determining FDA’s device classification, the scanning environment(s), whether a PI must be included in the barcode and which GS1 barcode the labeler will use.
With the applicable GS1 standard being AIs, the new information on PIs cover how to encode an AI into a GS1 barcode, the AI syntax, production and expiration dates, serial numbers and batch or lot numbers.
HRI rules and principles have been added to the implementation guideline as well. GS1 US says sector-specific HRI rules “must be aligned with the general HRI rules, which “apply independent of sector, product category or region.” Principles relate to HRI location, font and data printing and expressing. For UDI direct marking requirements, the updated guideline points to direct part marking, durable labelling and durable radio frequency identification tagging as the three methods for permanently marked items.
The updated guideline also includes a few additional details on the Global Data Synchronization Network (GDSN)—a voluntary standard for requirements on uploading data elements to FDA’s Global Unique Device Identification Database (GUDID). The guideline’s 2014 version was largely focused on the GDSN.
“UDIs will be presented on device labels in both a human-readable format and a machine-readable format that can be read by automatic identification data capture technology,” says GS1 US. “UDI will provide a standardized way to identify medical devices across all information sources and systems, including electronic health records and devices registries.” GS1 US also issued an implementation guideline in January to support point-of-care capturing of UDIs presented on implantable devices.
Although most compliance dates having already passed, FDA pushed back UDI enforcement and compliance dates on certain device types—including device constituents of combination products in August 2018 and class I and unclassified devices in November 2018—categorized for the phased-in approach to implementing a nationwide UDI system as the transition has taken longer than anticipated. New UDI compliance dates came in recognition of issues some manufacturers continue to face partly due to a lack of understanding of the different UDI requirements. FDA issued final UDI guidance on convenience kits just last month.
The updates also come at a time when medical device manufacturers can, once again, make changes to their device records shortly after being published in AccessGUDID. FDA reverted to the original 7-day GUDID “grace period” as of 11 May from a temporary change to 30 days the agency made via 2014 final guidance. Lena Cordie, president and founder of consulting firm Qualitas Professional Services, previously told Focus that FDA’s December 2018 proposal to revert to the original seven days was “long overdue.” FDA had attributed the temporary change to an anticipated spike in submission volume.
The number of GUDID records reached the 2 million mark as of February. FDA analytics on these records show an uptick after each submission compliance date, including the September 2018 date for most UDI requirements on class I and unclassified devices. The only remaining compliance date is for reprocessed class I and unclassified devices to comply with permanent marking requirements by 24 September 2020.
Implementation guideline