In Brief: Class II Medical Device Labelers May Now Open FDA UDI Database Accounts

The US Food and Drug Administration has begun accepting account requests from labelers of Class II medical devices for the Global Unique Device Identification Database (GUDID).

US regulators have extended GUDID access ahead of a September 2016 UDI compliance deadline for Class II medical devices.

The FDA advises that Class II device labelers collect and validate data before applying for GUDID accounts or submitting UDI records.

The agency refers potential applicants to its online GUDID preparation and UDI training resources.