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FDA Opens GUDID to the Public

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 new portal created by FDA in collaboration with the National Library of Medicine (NLM).  Users can download all GUDID data at once, or they can search for specific information by a device identifier, a device name, or a company name.  GUDID device identifier records include information such as device characteristics (whether a device is single use, prescription use, over the counter, etc.), device status, and more.  The database does not contain any information regarding patients or others who use a device.

FDA’s UDI rule is being implemented in phases, so the GUDID currently only contains data for Class III devices.  Class II devices must be in compliance with the UDI rule by September 24, 2016 and class I devices by September 24, 2018.  As of May 4, there were 48,093 device identifier records in the database.  GUDID data is updated each business day.

Registrar Corp helps medical device companies comply with U.S. FDA regulations and offers assistance with FDA’s UDI and GUDID requirements. We can help device companies determine the UDI requirements particular to a specific device, as well as help submit information to GUDID.  If you have questions about UDI and GUDID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.