UDI Database Goes Public with High-Risk Device Info
The U.S. FDA has taken a giant step toward encouraging the use of unique device identifiers, with the launch of a public website making UDI data available to the public.
AccessGUDID debuted May 4 and allows users to search for and download any information labelers have submitted about medical devices. For example, an MRI technician might use the database to learn whether a patient’s implanted device is safe for use while undergoing a scan.
Specific information available through AccessGUDID includes the device identifier, device characteristics, such as safety information, whether the device is in commercial distribution, alternative identifiers and the manufacturer’s contact information.
The UDI program requires devicemakers to include an identifying code on the product’s label to make it easier to track postmarket data and to submit the data to the Global Unique Device Identification Database, or GUDID. The UDI final rule was issued in 2013, and the program took effect for high-risk devices last September. More device data will be added to the database as UDIs become mandatory for them.