US FDA Rolling Out Updates to UDI Database in 2018

EMERGO SUMMARY OF KEY POINTS:

• US FDA plans updates to its Global Unique Device Identification Database (GUDID) for Spring and Summer 2018.
• GUDID updates include new file data elements, record accessibility and premarket submission and supplement number requirements.

The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers.

According to the agency’s announcement, an initial round of GUDID updates will go into effect in late March 2018, followed by additional enhancements in late summer 2018.

March 2018 GUDID changes

FDA’s first round of GUDID updates for 2018 include two key components:

• UDI labelers will have the ability to unlock their device records following device identifier (DI) record grace periods in order to correct any errors or update their information, a move intended to reduce error correction requests submitted to the FDA UDI help desk.
• GUDID download files will include new data elements, including public version number and data, public version status, public device record key, labeler DUNS (Data Universal Numbering System) number, and premarket submission and supplement numbers.

Summer 2018 database updates

Later this year, FDA will release premarket submission and supplement numbers into GUDID. (The agency notified stakeholders in January 2018 of this move.) Companies should make sure that their GUDID records include all necessary listing numbers, and that they have designated any proprietary information related to their devices as confidential in their GUDID records. The confidentiality issue is important because FDA continues to weigh whether to make premarket submission and supplement numbers publicly accessible.

Additional FDA medical device regulatory and UDI information from Emergo:

• US FDA Unique Device Identification (UDI) compliance consulting
• FDA regulatory consulting for medical device and IVD companies
• Video overview: The US FDA UDI system
• Whitepaper: Understanding the US FDA UDI regulation