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

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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
04/27/2020	HL7 SPL Implementation Files (ZIP - 1.9MB)
04/27/2020	GUDID Data Elements Reference Table (XLSX - 326KB)
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)