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FDA Unique Device Identification (UDI) Program

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 relevant details.

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 providers.

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.