• Medical Devices

  What is a GUDID AKA Global Unique Device Identification Database

  Posted by Mark Anderson on October 25, 2022 at 4:16 am

  What is a GUDID?

  The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with a unique device identifier (UDI).

  GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database. While GUDID does not include production identifiers (PIs), GUDID contains PI flags to indicate which PI attributes are in the UDI.

  Accessing Information of GUDID

  To access information of the GUDID, public can make use of AccessGUDID, a portal created by the FDA in collaboration with the National Library of Medicine. AccessGUDID can be used to access the data of a medical device or to download the entire database at once.

  There are two ways to submit the device identification information to GUDID.

  1. GUDID Web Interface – Device information can be submitted in a structured format as one DI at a time.

  2. HL7 SPL Submission – Device information can be submitted in XML format.

  In both the cases, a GUDID account is required to submit the device information. Although, it is not required for searching purpose.

  GUDID Submission Process

  Before getting a GUDID account, medical device manufacturers take a number of steps to organize, collect and validate the data. At times, they store the data at multiple locations which makes it difficult to coordinate while preparing data for GUDID. To ensure the readiness of data to submit to the GUDID, manufacturers are urged to follow the below-mentioned steps:

  1. An internal action plan/timetable must be prepared with the help of UDI guidance documents and resources for preparing data for GUDID

  2. For assigning and maintaining UDIs, consult FDA-accredited issuing agencies along with establishing processes for physical labeling

  3. Standard operating procedures (SOPs) should be established for records management

  4. Based on Data Elements Reference Table, data should be gathered for GUDID DI records

  5. The GUDID account structure and user roles must be understood thoroughly
     Individuals should be identified for the user roles of GUDID and it should be made sure that they understand the functionality and responsibilities of the role

  6. Obtain DUNS (Data Universal Numbering System) number

  7. For existing numbers, the information should be verified before using and should be updated, if necessary

  8. For non-existing numbers, a DUNS number should be obtained from D&B

  9. Identify which submission option is suitable for the device

  10. In case of HL7 SPL submission, create an FDA ESG account and complete the testing

  11. If required, consult a third party submitter

  Mark Anderson replied 2 years, 1 month ago 1 Member · 0 Replies
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