Feb 2, 2016
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.
US medical device regulators at the Food and Drug Administration have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.
Medical device market regulators in the US have launched a new website to provide public access to their Global Unique Device Identification Database (GUDID) designed to store device labelers’ information about their products.