What is GUDID?

Global Unique Device Identification Database (GUDID) is a reference catalog for each medical device with an identifier, under the supervision of the Food and Drug Administration (FDA). It contains information related to the key device identification of medical devices submitted to FDA with a Unique Device Identifier (UDI). As per the rule of UDI, information related to all the medical devices labeled with a UDI must be submitted to the GUDID, unless an exception is mentioned. The primary key used for extracting the information from the database is called the device identifier (DI). It is the only element stored in the GUDID, which also contains Product Identifier (PI) flags to identify all the PI attributes on the device label.

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:

• An internal action plan/timetable must be prepared with the help of UDI guidance documents and resources for preparing data for GUDID
• For assigning and maintaining UDIs, consult FDA-accredited issuing agencies along with establishing processes for physical labeling
• Standard operating procedures (SOPs) should be established for records management
• Based on Data Elements Reference Table, data should be gathered for GUDID DI records
• 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
• Obtain DUNS (Data Universal Numbering System) number
  
  • For existing numbers, the information should be verified before using and should be updated, if necessary
  • For non-existing numbers, a DUNS number should be obtained from D&B
• Identify which submission option is suitable for the device
  
  • In case of HL7 SPL submission, create an FDA ESG account and complete the testing
• If required, consult a third party submitter
• For information about UDI programs and GUDID systems, subscribe to UDI mailing list and GUDID mailing list respectively

Electronic systems like GUDID enable manufacturers to submit and keep a track of their data efficiently. For more information regarding GUDID and UDIs, consult an expert. Drop us an email at sales@freyrsolutions.com.