What is Unique Device Identification?
U.S. Food and Drug Administration (FDA) has established a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in a human and machine-readable format. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the FDA at AccessGUDID. The UDI system, which is being phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. FDA states UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. Philips recognizes and supports the MHS mission—which extends beyond combat medicine to healthcare delivery, education, public health, R&D and private sector partnerships to advance health for the Defense community. Click here to subscribe to new articles.
What are the GS1 standards?
When will UDI be implemented?
Labels and packages must bear UDI for devices manufactured after the relevant compliance dates except where the rule provides for an exception or alternative.
September 24, 2014 Class III Medical Devices (majority of Personal Care products)
September 24, 2015 Class II implants and life-supporting/sustaining devices
September 24, 2016 All other Class II devices (majority of Philips Heathcare products)
September 24, 2018 Class I devices (majority of Personal Care products)
What does it mean to the customer?
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.
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