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:
- September 2014: Class III devices and software; devices licensed under the US Public Health Service Act
- September 2015: Implantable, life-supporting and life-sustaining devices and software
- September 2016: Class II devices; direct marking for Class III devices for some intended uses
- September 2018: Class I devices; devices not classified as Class I, II or III; direct marking of Class II devices for some intended uses
- September 2020: Direct marking of Class I devices and devices not classified as Class I, II or III for some intended uses
Author
- Stewart Eisenhart