FDA UDI Testing

Summary of UDI

To ensure accurate identification and traceability of medical devices, the FDA has implemented Unique Device Identification (UDI) requirements.  Compliance dates are based on device classes:

Compliance Date Requirement
September 24, 2014 The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.
September 24, 2015 The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.
September 24, 2016 The labels and packages of class II medical devices must bear a UDI.
September 24, 2018 The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI.

The GS1 Organization is one of the  FDA authorized issuing agencies for UDI and has developed standards that support the FDA’s requirements.  The standards cover the formatting, dimensions, and print quality for barcode symbols carrying UDI data, as well as the numbering system used to uniquely identify devices and the data formatting for relevant data fields.

As a GS1 Solution Provider with a number of GS1 Certified Professionals and GS1 Certified Consultants on staff, Identification Labs can assist companies with barcode and packaging certification, data validation, and data migration.

UDI Label Certification

All relevant UDI data fields must be encoded in a barcode on the device packaging or in some cases directly on the device. Identification Labs can assist companies that need to certify that their UDI barcodes and marking meet UDI requirements.  Our labs employs a variety of barcode verification devices, all GS1 certified, to evaluate barcode symbols.

Testing results provide a detailed analysis of any issues and provide easy to understand resolutions.  All results are backed by our qualified staff that can provide one-on-one support by phone, email, and web-conferencing.

Data assistance

A key component of the FDA’s UDI requirements is the development of Global UDI Database (GUDID).  The GUDID serves as a catalog for key device information.  Companies are required to enter this information into the GUDID as part of UDI compliance.

Identification Labs has extensive experience with this type of data migration and offers data assistance services for the validation and uploading of GUDID data.