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VA Technical Reference Model v 24.2

UDI (Unique Device Identification), Food and Drug Administration
UDI (Unique Device Identification), Food and Drug Administration Standard or Specification

General InformationGeneral Information help

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

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Description: FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human and machine-readable form. Device labelers must also submit certain information about each device to FDA`s Global Unique Device Identification Database (GUDID). The public will be able to search and download information from the GUDID.

The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.

This standard requires device labelers to 1. Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. If a device is intended for more than one use and intended to be reprocessed before each use, the device labeler must also mark the UDI directly on the device. 2. Submit device information to the Global Unique Device Identification Database (GUDID).

Health IT applications and systems should be able to record Unique Device Identifier(s) (UDI(s)) associated with a patient’s implantable device(s).
Technology/Standard Usage Requirements: Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:
Decision: View Decisions

Decision Source: TRM Mgmt Group
Decision Process: One-VA TRM v23.5
Decision Date: 05/23/2023 at 18:33:01 UTC
Introduced By: Enterprise Program Management Office (EPMO) TRM Team
Standards Body: FDA
- The information contained on this page is accurate as of the Decision Date (05/23/2023 at 18:33:01 UTC).