GUDID
The U.S. FDA’s Device Identification Database
What it is:
The Global Unique Device Identification Database (GUDID) is managed by the U.S. Food and Drug Administration and serves as the central repository for device identification data. Each device marketed in the U.S. must have a Unique Device Identifier (UDI) recorded in GUDID.
Who is affected:
- Medical device manufacturers and labelers marketing devices in the U.S.
- Distributors ensuring correct labeling and data synchronization with the FDA.
What it requires:
Manufacturers must assign a compliant UDI, submit key product information (device name, version, packaging, sterilization status, etc.) to GUDID, and ensure that labeling aligns with FDA requirements.
On osapeers, professionals discuss:
- Synchronizing data between EUDAMED (EU) and GUDID (U.S.) for global compliance.
- Managing multi-market data submissions efficiently.
- Using global standards (like GS1) to maintain interoperability across systems.
