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Posts tagged ‘GUDID’

The U.S. Food and Drug Administration (FDA) extended the Global Unique Device Identification Database (GUDID) submission compliance date for all labelers required to submit data to the GUDID by September 24, 2015 to October 24, 2015. The extension is the result of GUDID security vulnerability issues that have caused FDA to temporarily take the GUDID […]

The September 24, 2015 Unique Device Identifier (UDI) compliance date is quickly approaching. Life-supporting and life-sustaining device labelers, as well as most contact and intraocular lens labelers, have only two months left to comply with the U.S. Food and Drug Administration’s (FDA) UDI labeling and Global Unique Device Identification System (GUDID) requirements. Implantable device labelers […]

On May 4, 2015, the U.S. Food and Drug Administration (FDA) announced that the Global Unique Device Identification Database (GUDID) is now open to the public. The GUDID contains data regarding medical devices that are required to bear a Unique Device Identifier (UDI).   Users can access GUDID data through AccessGUDID, a beta version of a […]

The U.S. Food and Drug Administration (FDA) hosted two webinars on January 14, 2015.  Yesterday, Registrar Corp published a summary of the first webinar, “UDI 101.”  Today we’re summarizing FDA’s second webinar, “Getting Ready for GUDID.” “Getting Ready for GUDID” was presented by Indira R. Konduri, FDA’s GUDID Program Manager.  She offered a list of […]

FDA Plans for UDI in 2015

December 23, 2014

On December 18, 2014, the U.S. Food and Drug Administration (FDA) sent out an e-mail update regarding the Unique Device Identification (UDI) system.  The update covered information about upcoming compliance dates and FDA’s plans for the system in 2015. The next two UDI compliance dates are: September 24, 2015 for non-class III implantable, life-supporting, and […]

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