FDA Issues GUDID Draft Guidance

Medical-Devices_670x330Important news for medical device manufacturers who need to label their Class III medical devices. The FDA has issued the Global Unique Device Identification Database (GUDID) draft guidance. This document contains all of the information labelers need to know about submitting data to the database.

The GUDID stores key device information, and contains only the device identifier (DI). The DI is the primary key used to get device information in the database. You can submit your DI information in one of two ways:

  • Submit one Device Identifier (DI) record at a time via the secure GUDID Web Interface.
  • Submit one DI record per XML file using the HL7 SPL submission option of the FDA Electronic Submissions Gateway (ESG)

The  Draft Technical Specifications for the GUDID HL7 SPL submission option is now available on the GUDID website. Labelers who want to submit information to the GUDID using the HL7 SPL option must:

  • Obtain a digital certificate and register with the FDA Electronic Submission Gateway (ESG).  Detailed information is available on the ESG website here
  • Request a GUDID account by clicking here 

For all questions on UDI and GUDID, please contact the FDA UDI Help Desk.

Share Button

Speak Your Mind

*