UDI Training

UDI Training:

On July 9, 2012, the FDA Safety and Innovation Act was signed into a legal document, requiring the FDA to establish a new UDI system. Until September 24, 2013, the FDA issued the Final Regulation, which mandatorily required devices to be identified using UDI for sale and use.



UDI consists of two parts: DI and PI. The Device Identification (DI) code is a fixed and mandatory part of UDI, which includes label information and product model number. The Production Identification (PI) code is a variable and non mandatory part of UDI, which generally includes information such as batch number, serial number, expiration date, production date, etc. Labelers can select appropriate PI information according to product needs. The stickers here refer to the manufacturer of the product or the importer who imports the product into the United States under their own brand.



UDI must appear on the product label and packaging in two forms simultaneously: 1. A directly readable plain text version, such as numbers and letters; 2. Machine readable automatic recognition and data acquisition technology (AIDC) formats, such as barcodes, QR codes, RFID, etc. For independent software, if the software has packaging, the above two forms must appear on the packaging. For software, regardless of whether it is packaged or not, as long as it is inside the software, such as in the software description or at the beginning of the software, provide one or both forms of UDI



Labelers also need to submit their registered product UDI information to GUDID (Global UDI Database). When submitting the registered product UDI information, they only need to submit the DI code, not the PI code, but need to fill in the relevant information contained in the PI in the system.