What is the difference between GDSN and GUDID?
Information and advice about GDSN and GUDID for Medical Device Manufacturers
Distinguishing between GDSN and GUDID can sometimes result in confusion. GS1 US's Director of Global Standards, Scott Brown, was kind enough to give us some clear distinctions between the two.
The U.S. FDA's Global Unique Device Identifier Database (FDA GUDID) is a regulatory repository of basic device information for public viewing. The FDA GUDID provides a subset of information about a device. It is a regulatory database and has a prime purpose of identifying devices in the market and for eventual use for adverse event reporting.
Global Data Synchronization Network (GDSN) is an electronic messaging service which allows for the sharing of product information between buyers and sellers. Information which can be shared includes regulatory, supply chain, marketing, and other. This messaging is intended to provide a complete set of information which is needed for a device to be set up and sold in the marketplace. This data can be shared loaded one time by a seller and shared with any and all buyers of that product.
GUDID and GDSN each serve a different purpose.
The U.S. FDA's GUDID is a regulatory requirement and must be loaded according to the FDA Specifications. There are 2 options for loading- Online Web data entry (manual) and Machine to Machine using file transfer protocols. The Machine to Machine option can be accomplished by your company or using a 3rd party such as a GDSN Data Pool.
The GDSN is for broad based use of sharing all of the information about a device/item with any buyer. It can also be used as a 3rd party to load the FDA GUDID using the Machine to Machine approach. GDSN is typically used by buyers to load product information into their backend systems
Is use required or needed?
The FDA GUDID is a regulatory requirement for labelers of device to load. A labeler must have all of their devices in the marketplace loaded according to the timetable set forth in the UDI Rule.
The GDSN is a choice between a seller and a buyer. GDSN is the most efficient means of sharing product information. It will also contain information not found in FDA GUDID which buyers will need to be able to make purchasing and use decisions.