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  5. UDI Rule and Guidances, Training, Resources, and Dockets
  1. Device Advice: Comprehensive Regulatory Assistance

UDI Rule and Guidances, Training, Resources, and Dockets

UDI Rule and Guidances, Training, Resources, and Dockets

This page provides a comprehensive list of links to:


UDI Rule and Guidances

Date Topic Guidance or Rule
04/26/2019 Convenience Kits Unique Device Identification: Convenience Kits - Guidance for Industry and Food and Drug Administration Staff
11/05/2018 Compliance Dates – Class I, Unclassified Devices; Direct Marking for Non-Sterile Inventory Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect 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
08/30/2016 NHRIC and NDC Codes Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff
07/25/2016 UDI Form and Content (draft) Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff
08/14/2016 GUDID Submission Compliance Date of September 24, 2015 Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - 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
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 Training for Industry

Date Topic Training (Format and Content)
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
03/11/2019 GUDID Data Elements Reference Table (XLSX - 326KB)
03/30/2018 GUDID Manual: Unlocking Device Records for Editing (PDF - 427KB)
03/30/2018 HL7 SPL Implementation Files (ZIP - 1.6MB)
01/27/2017 UDI Formats by FDA-Accredited Issuing Agency (PDF - 203KB)
05/2014 GUDID User Manual (PDF - 2.2MB)

UDI Dockets



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