UDI (Unique Device Identification) labeling is a requirement of the FDA for most medical device products. The point of UDI is to enhance product traceability throughout the supply chain, from the factory dock to the clinical use environment. The key labeling elements include device identifiers (DI) (i.e. the “GTIN” number), production identifiers (PI) (i.e. lot number), and expiration dates, presented on each product label in both barcodes and human-readable formats. Furthermore, medical device manufacturers must register this information with the FDA’s GUDID database, which allows users downstream in the supply chain to look up the part in a centralized database. Health care professionals rely on all this information to properly use, store and locate devices. More importantly, regulatory leaders are increasing labeling scrutiny.
As of 2020, Unique Device Identification is in the active compliance stage.
There are four steps for successful UDI implementation:
- Identify all sealable SKU’s/ configurations, then obtain “GTIN” numbers for each – the GTIN becomes the “Device Identifier” (DI). FDA-accredited issuing agencies include GS1, HIBCC, and ICCBBA.
- Ensure labels are properly formatted, which will include the “Device Identifier” (DI) (the GTIN number obtained in the step above) + “Production Identifier” (PI) which is usually the lot/expiration date. This information must appear as a barcode (1-D or 2-D are both acceptable) along with the human-readable text.
- Register with the FDA’s Global UDI Database (GUDID). This is a publicly searchable repository.
- Implement UDI rollout according to established FDA timelines
Avoiding the risk of smudged or damaged labels can be as simple as employing proper material testing methods. Sutherland Rub testing is a cost-effective step to assess your current materials and process, with the opportunity to consider other material or technology options if risks are found.
Labeling compliance and quality are straightforward issues to tackle. PCL can help you gain FDA approval efficiently and inexpensively.
UDI Compliance Podcast Episodes
We recently had the awesome opportunity to partner with Charlie Webb of Spot Radio for a two-part series on UDI Compliance. Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance Labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.
*This blog was originally published in April 2018 and has been updated since then.