Database of Medical Devices is Public

The Global Unique Device Identification Database (GUDID) is part of the FDA’s Unique Device Identification (UDI) Rule.  The database is managed by the FDA and is accessible to the general public.  The database is a reference catalog for every medical device with a Unique Device Identifier (UDI) attached to it.
 
According to the Draft Guidance for Industry, the database will contain product information, such as registered trade name, dimensions, storage conditions and packaging hierarchy.

The FDA says A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.

Medical device manufacturers are required to have UDIs on their products and submit product information to the GUDID by September 24, 2014.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.