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Posts tagged ‘UDI’

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 […]

You may be surprised by the number of different Unique Device Identifiers (UDIs) a company may need for a single type of device. A separate UDI is needed for certain variables, such as: Size Color Material Style Package Size For example, if the same surgical glove was available in latex and vinyl, each glove would […]

On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices.  Most devices will soon be required to bear a UDI on their labels and packaging.  For a device that is intended to be used more than once and intended […]

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 […]

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