The US Food and Drug Administration (FDA) plans to update its Global Unique Device Identification Database (GUDID) for medical devices in spring and summer 2018. The database updates are in line with feedback and requests from medical device manufacturers.
The GUDID is a database administered by the FDA that serves as a reference catalog for every device with an identifier. Under the Unique Device Identification (UDI) rule, the labeller of each medical device labelled with a UDI must submit information regarding that device to the GUDID, unless the device is subject to an exception or alternative.
According to the FDA, initial enhancements will go into effect in late March 2018, with additional updates following in late summer 2018. Updates include new file data elements, record accessibility and premarket submission and supplement number requirements.
Updates scheduled for late March 2018:
- “Labellers will be able to ‘unlock’ their device records after the device identification record grace period to make error corrections. This will eliminate the need to contact the FDA UDI Help Desk to make error corrections after the grace period.”
- The following new data elements are to be added to the GUDID download files: Public version number, public version date, public version status, public device record key and labeller DUNS number.
In summer 2018, the FDA plans to release premarket submission and supplement numbers into GUDID. Stakeholders were notified of this move by the FDA in January 2018. It is recommended that companies make sure their GUDID records include all the required listing numbers, and that they have designated any proprietary information related to their devices as confidential in their GUDID records. The FDA is considering whether to make premarket submission and supplement numbers publicly accessible, thus the confidentiality issue is important.
To view the email sent out to GUDID email subscribers, please click here.