The Food and Drug Administration (FDA) is establishing a Unique Device Identification (UDI) system to standardize and adequately identify medical devices through their distribution and use. When fully implemented, the label of most medical devices will include a unique device identifier in human and machine readable form. The unique device identifier is a unique set of alphanumeric codes consisting of both a Device Identifier (company and product code) and a Production Identifier (specific manufacturing information). Device labelers must also submit particular information about each device to the FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the GUDID at AccessGUDID.
The UDI system, which will be phased in over several years, offers a number of benefits that will be fully realized with the adoption and integration of unique device identifiers into the healthcare delivery system. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
You can learn more about this FDA requirement and the benefits of UDI across the healthcare industry by visiting the FDA website.
The UDI system offers a number of benefits that will be more fully realized with the adoption and integration of unique device identifiers into the healthcare delivery system.
ResMed will introduce UDI labeling as a rolling change across its products intended for sale in the US, over the course of several years.