What is a unique device identifier (UDI) and why does it matter?
A UDI is a unique numeric or alphanumeric code, that is placed on medical devices to identify them. This identifier must be provided in two forms on labels and packages-plain text and machine-readable. The purpose of a UDI is to improve the accuracy and completeness of adverse event reporting, product recalls, and other safety-related activities.
It will also help patients, providers, and payers better track medical devices throughout their life cycle.
The FDA is responsible for issuing regulations on the use of UDIs, and they have established a UDI rulemaking process to develop these regulations. In September 2013, the FDA released a proposed rule that would require most medical devices to bear a UDI.
The implementation of UDIs has been phased in over a period of years, with different timelines for different types of devices. Class III devices, which are those that support or sustain human life, were required to have UDIs by September 24, 2016. Class II devices, which are those that pose a moderate risk to the patient, were required to have UDIs by September 24, 2018. And Class I devices, which are low-risk devices, must have UDIs by September 24, 2020, even though the FDA will not enforce Class I UDI labeling before September 24, 2022.
So what does this mean for you? If you are a manufacturer of medical devices, you will need to comply with the UDI regulations when they are finalized. This may require changes to your labeling and packaging processes. You will also need to register your devices in the FDA’s Global Unique Device Identification Database (GUDID) and submit data about your devices on a regular basis.
UDIs have the potential to improve patient safety and reduce costs throughout the healthcare system. We encourage you to stay informed about the UDI rulemaking process and how it may affect you.
For more information on how Compliance Insight can help your company with the UDI process, please visit our website at www.compliance-insight.com