The Global Unique Device Identification Database, also known as GUDID is governed by US FDA. Since its origins in 2013, the goal of GUDID is to strengthen public health by enforcing standards to ensure safety, security and reliability. Medical devices that are marketed in the US have a regulatory obligation to submit specific product data to GUDID for compliance. FDA has published final guidance for Class I, unclassified devices, Class II and Class III. Specific scenarios apply per device category. Learn more in the ‘Understanding UDI Series’ about the regulations, scenarios and data elements required.
