GENICON, Inc. Announces Compliance with FDA’s – Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) Requirements.

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Global Unique Device Identification Database (GUDID) Requirements.

 

Winter Park, FL – August 30, 2016 – GENICON, a U.S. medical device company, has met the requirements for the Food and Drug Administration (FDA) Unique Device Identification (UDI) Final Rule for device labeling and published the required information into the FDA’s Global Unique Device Identification Database (GUDID). This system will be utilized to adequately identify medical devices through their distribution and use.

When fully implemented, the Unique Device Identification System will offer a range of benefits to industry, FDA, consumers, health care providers and health care systems by some of the following objectives:

  • Facilitate the accurate identification of a device using the UDI that appears on the device’s label and device package.
  • Be able to easily access important information concerning the device.
  • Allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problems can be identified and corrected more quickly.
  • Provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries, leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • Enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Provide a foundation for a global, secure distribution chain that will help address counterfeiting and diversion, and prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.

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