FDANews
The QMN Weekly Bulletin

CDRH Adds Five Online Resources for UDI Program

May 20, 2016

The FDA has added five new modules to its CDRH Learn online platform covering the Unique Device Identification program.

The educational tool now features a regulatory overview of the UDI system and the basics on submitting information to the Global Unique Device Identification Database.

In addition, devicemakers can now learn about preparation and process for a GUDID account request, requirements for the GUDID identifier record, and submission options for GUDID HL7 SPL.

With implementation of the UDI program, devicemakers must include an identifying code on the product’s label to make it easier to track postmarket data. The data are submitted to the GUDID.

Stay up to date on regulatory stories like this one by subscribing to The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation.

 

View More Stories