Download GUDID Schema

New Data Elements

New on April 2, 2018: updates to AccessGUDID data! The following new data elements are now available on AccessGUDID, in the download files, and in the APIs. More easily track GUDID device record updates, manage changes, and link to other data sets.

  • Public Version Number
  • Public Version Date
  • Public Version Status (new/update/delete)
  • Public Device Record Key
  • Labeler D-U-N-S® Number
  • FDA Premarket Submission Number*
  • FDA Premarket Supplement Number*

The updated schema file, sample download records and read-me-first files are included in the zip file below. Please take a moment to review the information and ensure your system is able to download and process the updated files.

* As of July 9, 2018, values for FDA Premarket Submission Number and FDA Premarket Supplement Number are included in the device record when available and publicly releasable.

Device record versioning is new

Starting April 2, 2018, you can track changes to device records using the new data elements Public Version Number, Public Version Date, Public Version Status, and Public Device Record Key.

Public Device Record Key is the primary key for device records on AccessGUDID: it can be used to uniquely identify a device record and maintain its history. Public Device Record Key will never change for an individual device record even if the device record’s Primary Device Identifier (DI) Number changes.

The table below shows the information you can expect to see in the new data elements Public Version Number, Public Version Date, and Public Version Status.

Action Public Version Number Public Version Date Public Version Status Device Record Status Additional Information
Record released to AccessGUDID for the first time 1 Date the record is initially released to AccessGUDID New Published
Record update released to AccessGUDID Add 1 to previous Public Version Number Date the updated record is released to AccessGUDID Update Published
Record is removed from AccessGUDID Add 1 to previous Public Version Number Date the record removal notification is sent to AccessGUDID Delete Unpublished/Deactivated Record will no longer be searchable via AccessGUDID Search interface or APIs
New data elements added to existing records on AccessGUDID on April 2, 2018 2 April 2, 2018 Update Published Public Version Number 1 of the existing records is implied prior to April 2, 2018

Current Schema File

The GUDID schema file is a ZIP file containing XSD files. The XSD files explain the format for GUDID release XML files. The GUDID schema ZIP file also contains an Excel file with version history for the XSD files.

Previous GUDID Schema File