How Can GS1 Standards Help Your Company Meet FDA UDI Requirements?

Accredited Issuing Agency for FDA Unique Device Identification

The U.S. Food and Drug Administration’s (FDA) rule requiring manufacturers to label their products with unique device identifiers (UDIs) is final (Read the Unique Device Identification System Final Rule). The UDI system can help the FDA find problems with medical devices much earlier, track recalls more efficiently, and improve patient safety.

GS1, a leading global standards organization, is an FDA-Accredited Issuing Agency for unique device identifiers (UDIs). Global GS1 Standards, administered in the U.S. by GS1 US, are authorized for use by manufacturers to address requirements of the new FDA UDI regulation. GS1 US can assist your company to meet UDI requirements with proven product identification and barcoding standards used by over 2 million companies worldwide.

FDA Unique Device Identification Rule

The FDA UDI rule on the establishment of a Unique Device Identification System requires (with some exceptions) medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI). This system, comprised of the UDI code, application of the UDI to device labeling and packaging, and a related database (Global Unique Device Identification Database or GUDID), will provide a standardized way to identify devices across all information sources and systems, including electronic health records and devices registries.

Components of the FDA UDI System

The UDI is a unique numeric or alphanumeric codes that includes a device identifier (DI), which is specific to a device model, and production identifier (PI), which includes the current production information for that specific device, such as the lot or batch number, the serial number, expiration date or a combination.

The UDI must appear on the label in a human readable format, as well as in a manner that can be read by automatic identification and data capture (AIDC) technology, such as a linear or 2D DataMatrix barcode. A unique UDI must be applied to the “base package” and higher levels of packaging. Information about the UDI will be submitted to the FDA GUDID. Information submitted will be a standard set of basic identifying data attributes.

Implementation Timeline

The effective dates for UDI requirements are based on risk class after publication of final rule:

  • Class III – 1 year
  • Class II implants and life-supporting/life-sustaining devices – 2 years
  • The rest of Class II – 3 years
  • Class I – 5 years

Are you a healthcare manufacturer that is new to GS1 Standards? Learn how GS1 Standards can enable you to uniquely identify your products.

Are you already using GS1 Standards for production identification and marking? Access UDI tools and resources.

Why Should You Use GS1 Standards for FDA UDI?

  • Most widely used data standard - over 2 million companies worldwide
  • Experts in product identification since 1973
  • 2,600+ healthcare manufacturers are using GS1 Standards
  • Largest healthcare manufacturers are using GS1 Standards
  • Leading providers & GPOs are requesting GS1 Standards
  • Supports industry & FDA UDI requirements
  • Meets local and global market requirements
  • GS1 is an FDA-Accredited Issuing Agency for UDI