The FDA has established a new program called Unique Device Identification (UDI). The requirements establish a phased in system which creates unique medical device identifiers that are readable by both humans and machines. We can design labels to help you comply with this new requirement. You can access the FDA Guidance Document here- Unique Device Identification (UDI)
The FDA's Unique Device
Identification (UDI) program is a system that assigns a unique identifier to
medical devices sold in the United States. The goal of the UDI program is to
improve patient safety and reduce the risk of adverse events by making it
easier to identify and trace medical devices.
The UDI program requires
manufacturers to include a UDI on the label of each medical device they sell in
the US. The UDI consists of a device identifier and a production identifier,
which can be in the form of a barcode, radio-frequency identification (RFID)
tag, or human-readable text. The device identifier is a unique code that
identifies the specific type of device, while the production identifier
includes information about the device's production batch and serial number.
Having a UDI on a medical device
allows for more efficient tracking and recall of devices in the event of a
problem. It also helps healthcare providers accurately identify and document
the devices they use, which can improve patient care and reduce medical errors.
In addition to the UDI
requirement, the FDA's UDI program also includes a database called the Global
Unique Device Identification Database (GUDID). The GUDID is a publicly
available database that contains information about all medical devices with a
UDI. This information includes the device's name, model number, and other
The UDI program has been in effect
since 2013, and all medical devices sold in the US are now required to have a
UDI. The program has been successful in improving patient safety and helping to
identify and trace medical devices. However, there are still some challenges to
implementing the UDI program, including the need for more consistent data
quality and the need for more widespread adoption of the UDI system by healthcare
Overall, the FDA's UDI program is
a valuable tool for improving patient safety and reducing the risk of adverse
events related to medical devices. It is an important step towards a more
efficient and effective healthcare system, and will continue to play a crucial
role in the future of medical device regulation.