An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Unique Device Identification System (UDI System)

UDI Rule, Guidances, Training, and Other Resources

This page provides a comprehensive list of links to:

UDI Rule
UDI Guidances
UDI Training for Industry
UDI and GUDID Technical Documents

UDI Rule

Date	Topic	Guidance or Rule
09/24/2013	Final Rule	Final Rule - Unique Device Identification System (in the Federal Register)
11/19/2012	Amendment to Proposed Rule	Amendment to the UDI Proposed Rule (in the Federal Register)
07/10/2012	Proposed Rule	Unique Device Identifier Proposed Rule (in the Federal Register)

UDI Guidances

Date	Topic	Guidance or Rule
07/25/2022	UDI Compliance Dates for Class I and Unclassified Devices; Direct Marking; GUDID Requirements for Certain Devices	Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, and Certain Devices Requiring Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices
07/07/2021	UDI Form and Content	Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Guidance for Industry and Food and Drug Administration Staff
04/26/2019	Convenience Kits	Unique Device Identification: Convenience Kits - Guidance for Industry and Food and Drug Administration Staff
11/17/2017	Direct Marking	Unique Device Identification: Direct Marking of Devices - Final Guidance for Industry and Food and Drug Administration Staff
08/20/2014	UDI FAQs	Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff
08/13/2014	Small Entity Compliance Guide	Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff
06/27/2014	GUDID	Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff

UDI Training for Industry

Date	Topic	Training (Format and Content)
05/21/2019	UDI Convenience Kit Final Guidance	Webinar page with video presentation, slides, transcript: Unique Device Identification: Convenience Kit Final Guidance - (PDF 125KB)
05/14/2018	GUDID: Unlocking Records	PowerPoint: GUDID User Group Session: Unlocking (DI) Records for Edits - (PDF - 782KB)
11/30/2017	Direct Marking Final Guidance	Webinar page with video presentation, slides, transcript: Unique Device Identification: Direct Marking of Devices Final Guidance
11/17/2017	GUDID Data Quality	Workshop page with video presentation, slides, transcript: Optimizing GUDID Data Quality - August 3, 2017
03/10/2016	GUDID DI Record	CDRH Learn video module:CDRH Learn video module: The GUDID Device Identifier (DI) Record
03/10/2016	GUDID HL7 SPL Submission	CDRH Learn video module: GUDID HL7 SPL Submission Option
01/27/2016	GUDID Account Request	CDRH Learn video module: Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process
01/27/2016	UDI Overview	CDRH Learn video module: Unique Device Identification (UDI) System Regulatory Overview
01/14/2015	GUDID Basics	Webinar: Getting Ready for GUDID

UDI and GUDID Technical Documents

Date	Resource
06/25/2024	GUDID Data Elements Reference Table (XLSX - 331KB)
04/27/2020	HL7 SPL Implementation Files (ZIP - 1.9MB)
03/30/2018	GUDID Manual: Unlocking Device Records for Editing (PDF - 427KB)
01/27/2017	UDI Formats by FDA-Accredited Issuing Agency (PDF - 203KB)
05/01/2014	GUDID User Manual (PDF - 2.2MB)

Top