The database will allow consumers, healthcare providers, and product manufacturers to access information tracked on medical devices, with the end goal of improving patient safety, improving device postmarket surveillance, and facilitating medical device innovation.
The FDA launched an eagerly-anticipated database to allow consumers, healthcare providers and product manufacturers to access information tracked on medical devices.
The online Global Unique Device Identification Database, called AccessGUDID, follows almost 3 years after Congress mandated that medical devices be marked and tracked with unique identifiers. FDA’s database uses a unique device identification system to identify devices sold in the US, with the capability to track them from manufacturing through distribution to patient use, the FDA said.
When fully implemented, the label of most devices will include a UDI in human- and machine-readable form. Device labelers must also submit certain information about each device to AccessGUDID, where the public can search and download information.
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