GUDID Enhancements and 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 2.2 – 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

• Fixes to capture additional details in log file for troubleshooting submission processing issues

• Creation of an Ack3 schema
• Addition of “Submission Type” and “Environment” data elements to the Ack3

• Fixes to GUDID download file generation issues
• Fixes to GUDID Web application user navigation issues and tweaks to error messages

• 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)

• Fixes to GUDID Account creation
• Fixes related to GUDID HL7 SPL submission processing

• 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

• GUDID enhancements and fixes to accommodate Class II submission volume

• 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.

• Fixes to improve performance of GUDID HL7 SPL submission processing

• 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

• 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

• 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

• Added ability to submit Denovo (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.

• Enhancements to address GUDID security vulnerability.

• Addressed HL7 SPL submission issues 

• Changes and fixes to GUDID download files

• Implemented ability to generate GUDID download files

• 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

• 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.

• 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.

• 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.

• None.

• 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

• None.