Feb 3, 2014
The US Food and Drug Administration has published new training material to help medical device manufacturers comply with new Unique Device Identification (UDI) requirements in the country.
The FDA UDI system requires US medical device market registrants to set up and maintain accounts with a Global Unique Device Identification Database (GUDID). Once registrants have opened accounts, they can submit device identification information into the database according to FDA rules. UDI data entered into GUDID is publicly searchable.
The FDA’s GUDID account training presentation covers steps to request GUDID accounts and properly enter UDI data into the system, and also recaps high-level compliance requirements of the new UDI system.
As a reminder, US UDI compliance deadlines will be phased in over the next five years:
The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.
The US Food and Drug Administration has published a proposed rule that would require medical devices marketed in the US to be