UDI Rule, Guidances, Training, and Other Resources
This page provides a comprehensive list of links to:
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
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) |