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  1. Unique Device Identification System (UDI System)

GUDID Enhancements and Fixes

GUDID Enhancements and Fixes

GUDID Grace Period Update

The grace period for device identifier (DI) records submitted to GUDID is now set to seven (7) calendar days, as originally stated in the GUDID guidance. A record enters its grace period on the day after its publish date. During this seven-day grace period, the record remains private and fully editable. Once the grace period passes, the record is released to the public via AccessGUDID and openFDA. Existing published DI records submitted prior to the change are within their thirty-day grace period will now be subject to the seven-day grace period. All records that have completed their seven-day grace period will be released to AccessGUDID and openFDA.

For all questions and concerns, please contact us via the FDA UDI Help Desk.

Technical documentation will be updated soon and posted on the UDI webpage.

Release 2.4.5 - June 7, 2019

Enhancements and Fixes

  • Enhancement to allow edits to unlocked records with an inactive listing number and a valid commercial distribution end date
  • Fix related to GUDID HL7 SPL submission processing

Release 2.4.4 - April 19, 2019

Fixes

  • Fixes to field length validation for GUDID HL7 SPL submissions
  • Implementation of acceptable special character list for all GUDID submissions

Release 2.4.3 - March 8, 2019

Enhancements and Fixes

  • GUDID Grace Period reduced from 30 calendar days to the original 7 calendar days (as stated in GUDID Guidance)
  • GUDID HL7 SPL submission processing window changed from 7 calendar days to 3 calendar days
  • Fixes to address GUDID HL7 SPL submission processing
     

Release 2.4.2 - January 25, 2019

Enhancements and Fixes

  • Fixes related to edits to Package DI via GUDID HL7 SPL submission option
  • Added Labeler submitted GUDID HL7 SPL submission setID and versionNumber to export file
     

Release 2.4.1 - December 13, 2018

Enhancements

  • Enhancements to allow for submission of CDER approved FDA Premarket Submission Numbers 

Release 2.3.4 - November 7, 2018

Fixes

  • Fixes to upgrade to 128-bit encryption for DUNS number look-up
     

Release 2.3.3.1 - October 20, 2018

Fixes

  • Fixes related to GUDID HL7 SPL submission processing and minor UI fixes
     

Release 2.3.3 - August 24, 2018

Enhancements and Fixes

  • Added size types and a unit of measure to the Clinically Relevant Size section in GUDID
  • Fix related to exporting files in GUDID
     

Release 2.3.2 - July 9, 2018

Enhancements

  • Release of "FDA Premarket Submission Number" and "Supplement Number" fields (premarket numbers) in AccessGUDID and OpenFDA
  • Check digit validation for all GS1-issued DIs during the submission and editing of DI records in GUDID
     

Release 2.3.1 - May 31, 2018

Enhancements

  • Enhancements to improve DI record deactivation process

Release 2.2 - March 30, 2018

Enhancements

  • Added ability for GUDID Coordinator user to "unlock" device records to make error corrections for Published device records after the DI record grace period.
  • Addition of the following new data elements to GUDID download files made available on AccessGUDID and OpenFDA - Public Device Record Key, Public Version Number, Public Version Date, Public Version Status. Value for these data elements will be assigned by the FDA and are not submitted by the labeler. These data elements will allow GUDID data users to easily track device record updates.
  • Addition of Labeler DUNS Number to GUDID download files made available on AccessGUDID and OpenFDA

Release 2.1 - January 24, 2018

Fixes

  • Clean up and removal of legacy Search menu items on the GUDID Web application
  • Fixes related to user accounts and access

Release 2.0 - November 10, 2017

Enhancement and Fixes

  • Enhancement and fixes to address known issues and improve search, indexing and release of data to AccessGUDID and OpenFDA
Release 1.6.4 - August 25, 2017
Fixes
  • Fixes to capture additional details in log file for troubleshooting submission processing issues
Release ML 1.2.4 - June 1, 2017
Enhancement
  • Creation of an Ack3 schema
  • Addition of "Submission Type" and "Environment" data elements to the Ack3
Release 1.6.3 - May 5, 2017
Fixes
  • Fixes to GUDID download file generation issues
  • Fixes to GUDID Web application user navigation issues and tweaks to error messages
Release 1.6.2 - December 16, 2016
Enhancements and Fixes
  • Fixed errors with duplicate DIs in the export file
  • Improved validation for HIBCC Device Identifiers
  • Added "Package Type" to GUDID download file (available on AccessGUDID)
Release 1.6.1 - November 18, 2016
Fixes
  • Fixes to GUDID Account creation
  • Fixes related to GUDID HL7 SPL submission processing
Release 1.5.1 - August 22, 2016
Enhancements and Fixes
  • Removed uniqueness check from Direct Mark DI
  • Reduced the size of GUDID Download file sent to AccessGUDID from 100,000 records/file to 25,000 records/file
  • Fixed issues with GUDID Export file
Release 1.5 - July 22, 2016
Enhancements and Fixes
  • GUDID enhancements and fixes to accommodate Class II submission volume
Release 1.4 - April 22, 2016
Enhancements
  • Updated NDC/NHRIC Number validation and entry - NDC/NHRIC numbers may be 10 or 11 digits, and may include 2 hyphens.
  • Added ability to "ADD" Secondary Device Identifiers (DI) after the DI record grace period.
  • Added ability to submit "Previous Device Identifier" as part of a device record.
Release 1.3.4.1 - March 18, 2016
Fix
  • Fixes to improve performance of GUDID HL7 SPL submission processing
Release 1.3.4 - March 4, 2016
Enhancements
  • Enhancements to allow for editing DI records with inactive listing numbers
  • Added ability to submit a package of 1
  • Added ability for Coordinator users to view DI records
  • Added ability for Labeler Data Entry (LDE) users to view Draft DI records for their assigned Labeler DUNS Numbers
  • Added ability to accept 'Doing Business As' (DBA) name for Labeler DUNS numbers, so Company Name in GUDID matches company name on device label
Fixes
  • Fix to enable submission of long email addresses via HL7 SPL submission option.
  • Fix to enable exporting of all submitted DI records by logged in users
Release 1.3.3_Hotfix - October 2, 2015
Fix
  • Fix to GUDID web application to retain search filter after navigating away from the search results screen
  • Fixes to address GUDID HL7 SPL submission processing
Release 1.3.3 - September 18, 2015
Enhancements and Fix
  • Added ability to submit De Novo (DEN prefix) and PDP (N prefix) premarket submission numbers.
  • Fixes and enhancements to GUDID download files for AccessGUDID, including increasing the number of records per file to 100,000.
  • Fix to enable submission of international phone numbers less than 10 digits
  • Enhancements to GUDID Accounts Module, such as ability to refresh company information from DUNS database.
 Release 1.3.2_Hotfix - August 19, 2015
Enhancement
  • Enhancements to address GUDID security vulnerability.
 Release 1.3.2 - May 19, 2015
Fix
  • Addressed GUDID HL7 SPL submission issues 
 Release 1.3.1 - April 17, 2015
Fix
  • Changes and fixes to GUDID download files
 Release 1.3 - March 13, 2015
Enhancement
  • Implemented ability to generate GUDID download files
Release 1.2.3 - December 15, 2014
Fixes to GUDID HL7 SPL Module only
  • Fixed Commercial Distribution End Date update issues
  • Addressed processing issues for submissions with duplicate Premarket Submission Numbers
  • Addressed display issues with CBER Premarket Supplement Numbers
  • Include ability to receive Premarket Submission Numbers that are reclassified after approval
Release 1.2.2 - September 18, 2014
Enhancements
  • Enhancements to GUDID Editing -DI records entered via the GUDID Web Interface maybe edited via HL7 SPL after the grace period passes for the DI record.
  • Increase field size to 80 characters - Version or Model Number
  • Increase field size to 80 characters - Catalog Number
  • Changes to Storage & Handling Unit of Measure -- "millibar" has been added
  • GUDID Web Interface only - DI record history view now shows "automated system process" for DI record status change from Unpublished to Published status and updates to Commercial Distribution Status and Package Status.
Release 1.2.1 - May 2, 2014
Enhancements to GUDID HL7 SPL Module only
  • Addition of a new Production Identifier -- Donation Identification Number (DIN) -indicates the device is managed by a Donation Identification Number. This number can be found on the device label or packaging. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation; required attribute; must answer Yes/No
  • Changes to MRI Safety Status - the existing two questions have been combined into one question which reads -- What MRI safety information does the labeling contain? The list of values will include - MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.
  • New additions to the list of values for Sterilization Method -- Nitrogen Dioxide, Supercritical Carbon Dioxide, High Level Disinfectant and Liquid Chemical Sterilant were added
  • Changes to list of values for Size Type and Unit of Measure -- Weight, Pressure, Pore Size, Area/Surface Area, and Angle were added; Second Greatest Diameter and Third Greatest Diameter were removed; related Units of Measure were also added.
Release 1.2 - March 28, 2014
Enhancements
  • Addition of a new Production Identifier: Donation Identification Number (DIN)-indicates the device is managed by a DIN. This number can be found on the device label or packaging. The DIN is applicable to devices that are also regulated as Human Cell, Tissue or Cellular or Tissue-Based Products (HCT/Ps) and is a number that is assigned to each donation; required attribute; must answer Yes/No
  • Changes to MRI Safety Status: The existing two questions have been combined into one question which reads "What MRI safety information does the labeling contain?" The list of values will include: MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.
  • "Support Contact Phone" changed to "Customer Contact Phone"
  • "Support Contact Email" changed to "Customer Contact Email"
  • Date format change for Web Interface entry ONLY from yyyy/mm/dd to yyyy-mm-dd for the following fields: DI Record Publish Date, Commercial Distribution End Date and Package Discontinue Date.New additions to the list of values for Sterilization Method: Nitrogen Dioxide, Supercritical Carbon Dioxide, High Level Disinfectant and Liquid Chemical Sterilant were added.
  • Please note that HL7 SPL changes for the above are scheduled to be pushed as part of Release 1.2.1 -- to the GUDID preproduction environment by the end of April 2014 and to GUDID production environment by the beginning of May 2014. Updated documentation is available.
Fixes
  • None
Release 1.1- January 31, 2014
Enhancements
  • Ability to submit FDA Preferred Term (PT) Codes as stipulated in the Final UDI Rule, FDA has developed a new GUDID module, Find FDA PT Codes, to enable users to select a FDA PT Code for GUDID submissions until a GMDN PT code can be obtained from the GMDN Agency. FDA PT Codes are a unique 4-letter code assigned to each GMDN PT Name, in place of the GMDN PT Code. The Find FDA PT Code module is enabled in GUDID Release 1.1 and can be accessed via the GUDID Web Interface by Coordinator and Labeler Data Entry (LDE) Users of GUDID. These FDA PT codes can also be submitted in HL7 SPL xml submissions.
  • Changes to the folder naming structure for HL7 SPL submissions
Fixes
  • None
Release 1.0 - September 20, 2013
 
  • GUDID initial release

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