Unique Device Identification

Unique Device Identification

What is UDI?

Unique Device Identification (UDI) is an initiative to implement a unique identification label on all medical devices in the United States and implement an ongoing database and tracking process.

  • Required under the Food and Drug Administration Amendments Act of 2007

  • Draft rules published by FDA in July 2012 with lengthy comment and review period

  • Final rule/regulation published on September 24, 2013, including draft Global UDI Database (GUDID) guidance

The expected benefits of UDI include improved patient safety, enhanced recall process and operational efficiencies within the healthcare supply chain.

Manufacturers are required by law to comply with the UDI rules.

  • Potential enforcement actions for violations of UDI requirements include seizure, injunction, and civil and criminal penalties.
  • UDI rules do not require the use of GS1 standards (GTIN), but provides flexibility to suppliers to choose from GS1 or several other issuing agencies, including HIBCC.

  • GS1 standards and systems do provide suppliers with full compliance with the UDI final rule, including the ability to submit their data through the GS1 certified data pools.

  • Intalere supports GS1 over other options due to the significant investment and overwhelming support made throughout the supply chain to this standards agency.

Global UDI Database (GUDID)

The Global UDI Database (GUDID - sometimes referred to as "good ID database") in an FDA managed database of all UDI information to facilitate sharing of this information.

  • Manufacturers are required to publish minimum data set to GUDID according to proposed rules

  • Public user interface will be provided to GUDID information, once the initial data is uploaded and validated

  • Initially limited to Class III and related devices, and then will be expanded

Medical Device Classes

Medical device classification is based on level of regulatory control requirements and risks to public health and safety. Classification guidance is provided to manufacturers by the FDA according to specific guidelines.

  • Class III - Devices that require general controls and premarket approval, including most implantable devices. Examples - pacemaker, pulse generators, external defibrillators

  • Class II - Devices that require general controls and additional special controls such as labeling, performance standards or post market surveillance. Examples - powered wheelchairs, infusion pumps, surgical drapes

  • Class I - Devices that require only general controls. Examples - elastic bandages, examination gloves, hand-held surgical instruments

Implementation Timeline

All medical devices will be required to bear a UDI in accordance with the following timeline (compliance by end of year stated):

  • Year 1 (9/24/14): Class III devices and devices licensed under the PHS Act must be labeled, dated and published to the GUDID.

  • Year 2 (9/24/15): Class II/I implants and Life-Supporting/Sustaining Devices must be labeled, dated and published to the GUDID.

  • Year 3 (9/24/16): Remainder of Class II devices must be labeled, dated and published to the GUDID.Also, reusable Class III devices must be "permanent marked" on the product itself, if feasible.

  • Year 5 (9/24/18): Class I devices must be labeled, dated and published to the GUDID.Also, reusable Class II devices must be "permanent marked" on the product itself, if feasible.

  • Year 7 (9/24/20): Reusable Class I devices must be "permanent marked" on the product itself, if feasible.