UDI (Unique Device Identification), Food and Drug Administration

General Information

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.

Website:	Go to site
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

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Industry Standard, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
3

Current Decision Matrix (04/15/2015)

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.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2023

CY2024

CY2025

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

3

Unapproved

Approved w/Constraints
[1]

Decision Constraints


[1]	Please contact the VHA Office of Standards & Interoperability (Mailgroup: vhas&iresponseteam@va.gov) prior to implementation to obtain guidance and the VHA-endorsed version of this standard.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
Vendor Provided*	UDI Compliance Policies and UDI Rule Compliance Dates	FDA	The FDA is reminding device industry and unique device identification (UDI) program stakeholders that the enforcement policy described in Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages is applicable to devices labeled prior to September 24, 2023. Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements, including the prohibition on the use of certain legacy FDA identification numbers (National Drug Code (NDC) and National Health Related Item Code (NHRIC) numbers) on the label.
Best Practice	HL7 Cross Paradigm Implementation Guide: UDI Pattern	HL7	The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients. This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR. The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR). In accordance with the expressive capability of the HL7 standard being used to convey the instance and any standard-specific requirements (e.g., use of OID vs. URI): 1. Systems SHALL transmit the UDI value, SHALL do so using the Human Readable Form string (HRF) and SHALL ensure that the OID or URL identifying the UDI assigning system is specified. If the encoding format has both a regular and an exchangeable HRF syntax, the exchangeable syntax SHALL be used. Where a serial number is being conveyed and the intent of the instance is to identify a specific device, the UDI SHALL be included in the element which communicates that intention (if supported by the HL7 standard used) HL7 IG: UDI Pattern R2 Normative Page 13 June 2020 © 2020 Health Level Seven International. All rights reserved. 2. Systems SHALL transmit all components found within the UDI for which data element locations are defined for the HL7 standard used and SHALL ensure that the data present within the components matches the data conveyed within the UDI 3. When conveying the DI components, the system SHALL ensure that the appropriate OID or URL is declared 4. Where the HL7 standard being used supports both OIDs and URLs (i.e., V2), the system SHALL be capable of recognizing both approaches and recognizing their equivalence.
Requirement	170.315(a)(14) Implantable device list	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Policy	2015 Edition Health IT Certification Criterion§?170.315(a)(20) (Implantable device list)	Federal Register	We propose to adopt a new 2015 Edition certification criterion focused on the ability of a Health IT Module to record, change, and access a list of unique device identifiers (UDIs)?corresponding to a patient``s implantable devices (“implantable device list”), parse certain data from a UDI, retrieve the “Device Description” attribute associated with a UDI in the Global Unique Device Identification Database (GUDID), and make accessible to a user both the parsed and retrieved data. The proposed criterion represents a first step towards enabling health IT to facilitate the widespread availability and use of unique device identifiers to prevent device-related adverse events, enhance clinical decision-making related to devices, improve the ability of clinicians to respond to device recalls and device-related safety information, and achieve other important benefits, consistent with the fundamental aims of the HITECH Act?and the HHS Health IT Patient Safety Action and Surveillance Plan.
Policy	Unique Device Identification System	Federal Register	The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA``s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Standard Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Source	Name	Description
No components have been identified for this entry.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Collaboration and Electronic Workplace Productivity Software	Health Care

Technologies/Standards Relationships

Implemented By/Verified With:

No technologies have been identified with this standard.

Comparable Standards:

No comparable entries have been identified.

Associated Standards:

General Analysis

Adoption Benefits

Required device identifier for use in USCDI and US Core to meet the ONC Health IT Certification Program.

Inside VA

Budget and Performance

Inside the Media Room

National Observances

Special Events

VA Technical Reference Model v 24.3

General Information

Vendor Release Information

Current Decision Matrix (04/15/2015)

Decision Constraints

References

Standard Components

VA Categories View the VA Categorization Framework

Technologies/Standards Relationships

Implemented By/Verified With:

Comparable Standards:

Associated Standards:

General Analysis

Adoption Benefits

CONNECT

VA HOME

QUICK LIST

RESOURCES

ADMINISTRATION

VA Technical Reference Model v 24.3

General Information

Vendor Release Information

Current Decision Matrix (04/15/2015)

Decision Constraints

References

Standard Components

VA Categories View the VA Categorization Framework

Technologies/Standards Relationships

Implemented By/Verified With:

Comparable Standards:

Associated Standards:

General Analysis

Adoption Benefits

EMAIL UPDATES